REST: Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT01168596
• Collaborator: (none)
• Enrollment: 30
• Locations: 3
• Arms: 2
• Duration (Months): 29
• Patients Per Site: 10
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of the research study is to determine if rasagiline is an effective treatment for fatigue in patients with Parkinson's disease (PD).

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Rasagiline; Drug: Placebo	Phase 4

Detailed Description

Despite the fact that fatigue affects 40-50% of all patients with PD and is a leading cause of disability, we currently do not have any effective treatments for this symptom. Rasagiline is a well-tolerated and effective treatment for the motor symptoms of PD. Rasagiline is a MAO-B inhibitor that may decrease the breakdown of dopamine. Many patients report an improvement in their energy levels when on this medication. A proven treatment for PD fatigue would significantly improve the quality of life for numerous patients and their caregivers.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease: A Bi-Center, Placebo-Controlled Study (The REST Fatigue Trial)
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: sugar pill Placebo tablet, 1 per day, duration is approximately 12 weeks.	Drug: Placebo; Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Active Comparator: rasagiline Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Drug: Rasagiline; Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.; Other Names: Azilect

Outcome Measures

Primary Outcome Measures

1. Modified Fatigue Impact Scale (MFIS) [Change from baseline to week 12]

   The MFIS rates how much of a problem fatigue has caused the subjects during the past month, including the day of testing. It consists of 21 questions of fatigue on quality of life. Each subject is asked to circle the appropriate response for each item: 0=never, 1=rarely, 2=sometimes, 3=often, 4=always, 5=almost always. The minimum score is 0 and the maximum is 105. The higher the score, the more fatigue the subject.

Secondary Outcome Measures

1. Fatigue Severity Scale (FSS) [Change from baseline to week 12]

   The Fatigue Severity Score consists of a nine-item questionnaire to identify common features of fatigue. Patients are instructed to choose a number from 1 to 7 that indicates their degree of agreement with each statement, where 1 = strongly disagree and 7 = strongly agree. Scores can range from a minimum of 9 to a maximum of 63. The higher the score, the more fatigue the subject.

2. Multidimensional Fatigue Inventory (MFIS) [Change from baseline to week 12]

   The Multidimensional Fatigue Inventory (MFIS) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Subjects are instructed to choose a number from 1 to 5 that indicates their degree of agreement with each statement where 1 indicates that it is true and 5 that it is not true. There are positive and negative statements in the questionnaire. The range is 1 to 100, the higher the number the higher the fatigue.

3. PD Quality of Life Scale (PDQ39) [Change from baseline to week 12]

   PD Quality of Life Scale (PDQ39) is a 39-item questionnaire, which measures eight dimensions of health (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort) over the past 30 days. Dimension scores are coded on a scale of 0 (never) to 5 (always). The higher the score, the worse the quality of life affected by PD. The range for this test is 0 to 195. All eight dimensions are added for a total score.

4. Paced Auditory Serial Addition Test (PASAT) [Change from baseline to week 12]

   The Paced Auditory Serial Addition Test (PASAT) is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention. Where subjects are given a number (every 3 seconds for the first series and 2 seconds for the second series) and are asked to add the number they just heard with the number they heard before. This is a challenging task that involves working memory, attention, and arithmetic capabilities.

5. Finger Tapping [Change from baseline to week 12]

   The patient is asked to use the index finger on the side most affected by Parkinson's disease to tap for sixty seconds with the number of taps at 30 seconds and 60 seconds recorded.

6. Hand-grip Strength [Change from baseline to week 12]

   The patients use the hand on the side most affected by Parkinson's disease to grip the dynamometer with as much strength as they can for 3 consecutive tries. The highest score will be their maximal voluntary contraction (MVC). The subject then rests for 60 seconds. The subject is asked to try to maintain 70% of their MVC and the duration the subject is able to maintain above 50% of their MVC is recorded. Immediately after the maintenance test, the subject performs three more MVCs and each one is recorded. These results are the duration the subject is able to maintain above 50% of their MVC.

Other Outcome Measures

1. Parkinson's Disease Sleep Scale (PDSS) [Change from baseline to week 12]

   The Parkinson's disease sleep scale (PDSS) is a 15-item visual analogue scale that assesses the profile of nocturnal disturbances in Parkinson's disease patients. The severity of symptoms of sleep over the past week is marked with a cross along a 10 cm line (labeled worst to best state). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptom severe and always experienced) to 10 (symptom-free). The maximum score for PDSS is 150.

2. Marin Apathy Inventory (Apathy Evaluation Scale) [Change from baseline to week 12]

   The Marin Apathy Inventory (Apathy Evaluation Scale) is a 14-item inventory measuring apathy of the subject over the past 2 to 4 weeks. Subjects are instructed to choose an answer from 0 to 3: 0=not at all, 1 = slightly, 2 = some, 3 = a lot, to questions related to apathy. The range would be 0 to 42, the higher the score the worse the apathy.

3. Visual Analog Scale - Subset: Afraid [Change from baseline to week 12]

   The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).

4. State-Trait Anxiety Inventory (STAI) [Change from baseline to week 12]

   The State-Trait Anxiety Inventory (STAI) is 40-item psychological inventory based on a 4-point Likert scale. Higher scores are positively correlated with higher levels of anxiety. The range for this test is 0 to 160.

5. Becks Depression Inventory (BDI-II) [Change from baseline to week 12]

   The Becks Depression Inventory (BDI-II) is a 21-question inventory measuring the severity of depression. Each subject is instructed to choose an answer on a scale value of 0 to 3 with the total score from 0 to 63. Higher total scores indicate more severe depressive symptoms.

6. Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III) [Change from baseline to week 12]

   Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)is a 14-question inventory measuring the motor functions of patients with Parkinson's Disease. Each subject is rated on a scale of 0 to 4 with the total score from 0 to 56. Higher total scores indicate more impairment of motor function.

7. Visual Analog Scale - Subset: Confused [Change from baseline to week 12]

   The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).

8. Visual Analog Scale - Subset: Sad [Change from baseline to week 12]

   The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).

9. Visual Analog Scale - Subset: Angry [Change from baseline to week 12]

   The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).

10. Visual Analog Scale - Subset: Energetic [Change from baseline to week 12]

    The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).

11. Visual Analog Scale - Subset: Tired [Change from baseline to week 12]

    The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).

12. Visual Analog Scale - Subset: Happy [Change from baseline to week 12]

    The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).

13. Visual Analog Scale - Subset: Tense [Change from baseline to week 12]

    The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. A clinical diagnosis of idiopathic PD by a movement disorders specialist. All subjects will be diagnosed using the UK Brain Bank criteria (Hughes et al., 1992).

2. Age between 40-85 years.

3. Able to sign and understand informed consent; and cognitively able to carry out the procedures in the study

4. Stable on all PD medications for at least 30 days; and psychotropic medications for at least 90 days.

5. Treatment naïve subjects who are appropriate candidates to begin MAO-inhibitor monotherapy as treatment for their PD may also be included in this study.

6. Fatigue Severity Scale ≥ 36 (KRupps et al., 1989)

Exclusion Criteria:

1. Clinically significant medical disease that is associated independently with fatigue (e.g. significant cardiac or pulmonary disease, anemia, obstructive sleep apnea, liver or kidney failure).

2. History of neurological illnesses other than PD or a history of a significant head trauma (involving unconsciousness).

3. Evidence of secondary or atypical parkinsonism as suggested by the presence of any of the following: 1) history of stroke(s), 2) exposure to toxins or neuroleptics, 3) history of encephalitis, 4) neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear gaze palsy, or significant orthostatic hypotension.

4. MRI or CT scan with significant evidence of brain atrophy or other abnormalities (e.g. lacunar infarcts or iron deposits in the putamen.

5. Clinical diagnoses of dementia; or an MMSE score of < 25.

6. Unstable, newly diagnosed, or newly treated (i.e. less than 3 months) major psychiatric disorder such as depression or anxiety

7. Beck's Depression Inventory score >14.

8. Current or prior placement of Deep Brain Stimulator.

9. Currently taking an MAO-B inhibitor or medications which are used as fatigue treatments, including amantadine, modafinil, methylphenidate, atomoxetine or other psychostimulants.

10. Previously taken an MAO-B inhibitor for more than 2 weeks.

11. Hypersensitivity to rasagiline or its products

12. On mirtazapine, venlafaxine, regular use of compounds with vasoconstrictors, tramadol, meperidine, propoxyphene, dextromethorphan, St. John's wort, cyclobenzaprine

13. On omeprazole, ciprofloxacin or drugs that are metabolized through CYP1A2

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Anschutz outpatient Pavilion	Aurora	Colorado	United States	80045
2	Shands and University of Florida Medical Plaza	Gainesville	Florida	United States	32610
3	Cleveland Clinic Center for Neurological Restoration	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• University of Florida

Investigators

• Principal Investigator: Irene A Malaty, MD, University of Florida Department of Neurology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01168596
• Other Study ID Numbers: 20091035
• First Posted: Jul 23, 2010
• Last Update Posted: Jan 10, 2014
• Last Verified: Sep 1, 2012

• Keywords provided by University of Florida: Parkinson's Disease; Fatigue
• Additional relevant MeSH terms: Parkinson Disease; Fatigue; Rasagiline

Study Results

Participant Flow

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Period Title: Overall Study
STARTED	16	14
COMPLETED	13	13
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Rasagiline	Sugar Pill	Total
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.	Total of all reporting groups
Overall Participants	16	14	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.67 (7.39)	65.43 (6.42)	67.1 (7)
Sex: Female, Male (Count of Participants)
Female	5 31.3%	9 64.3%	14 46.7%
Male	11 68.8%	5 35.7%	16 53.3%
Region of Enrollment (participants) [Number]
United States	16 100%	14 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Modified Fatigue Impact Scale (MFIS)
Description	The MFIS rates how much of a problem fatigue has caused the subjects during the past month, including the day of testing. It consists of 21 questions of fatigue on quality of life. Each subject is asked to circle the appropriate response for each item: 0=never, 1=rarely, 2=sometimes, 3=often, 4=always, 5=almost always. The minimum score is 0 and the maximum is 105. The higher the score, the more fatigue the subject.
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [units on a scale]	12.92	12.69

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.81
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.30
	Confidence Interval	(2-Sided) 95%; -9.13 to 11.73
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.26
	Estimation Comments

2. Secondary Outcome

Title	Fatigue Severity Scale (FSS)
Description	The Fatigue Severity Score consists of a nine-item questionnaire to identify common features of fatigue. Patients are instructed to choose a number from 1 to 7 that indicates their degree of agreement with each statement, where 1 = strongly disagree and 7 = strongly agree. Scores can range from a minimum of 9 to a maximum of 63. The higher the score, the more fatigue the subject.
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	13
Mean (95% Confidence Interval) [units on a scale]	12.38	2.25

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.23
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	4.38
	Confidence Interval	(2-Sided) 95%; -2.75 to 11.51
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.60
	Estimation Comments

3. Secondary Outcome

Title	Multidimensional Fatigue Inventory (MFIS)
Description	The Multidimensional Fatigue Inventory (MFIS) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Subjects are instructed to choose a number from 1 to 5 that indicates their degree of agreement with each statement where 1 indicates that it is true and 5 that it is not true. There are positive and negative statements in the questionnaire. The range is 1 to 100, the higher the number the higher the fatigue.
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	13
Mean (95% Confidence Interval) [units on a scale]	2.62	6.83

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.75
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.61
	Confidence Interval	(2-Sided) 95%; -8.37 to 11.59
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.03
	Estimation Comments

4. Secondary Outcome

Title	PD Quality of Life Scale (PDQ39)
Description	PD Quality of Life Scale (PDQ39) is a 39-item questionnaire, which measures eight dimensions of health (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort) over the past 30 days. Dimension scores are coded on a scale of 0 (never) to 5 (always). The higher the score, the worse the quality of life affected by PD. The range for this test is 0 to 195. All eight dimensions are added for a total score.
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [units on a scale]	7.54	5.67

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.88
	Confidence Interval	(2-Sided) 95%; -4.18 to 7.94
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.06
	Estimation Comments

5. Secondary Outcome

Title	Paced Auditory Serial Addition Test (PASAT)
Description	The Paced Auditory Serial Addition Test (PASAT) is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention. Where subjects are given a number (every 3 seconds for the first series and 2 seconds for the second series) and are asked to add the number they just heard with the number they heard before. This is a challenging task that involves working memory, attention, and arithmetic capabilities.
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [units on a scale]	-11.31	-10.31

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.42
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-5.17
	Confidence Interval	(2-Sided) 95%; -17.76 to 7.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.36
	Estimation Comments

6. Secondary Outcome

Title	Finger Tapping
Description	The patient is asked to use the index finger on the side most affected by Parkinson's disease to tap for sixty seconds with the number of taps at 30 seconds and 60 seconds recorded.
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [finger taps per sixty seconds]	.46	-0.23

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.36
	Confidence Interval	(2-Sided) 95%; -0.56 to 1.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.47
	Estimation Comments

7. Secondary Outcome

Title	Hand-grip Strength
Description	The patients use the hand on the side most affected by Parkinson's disease to grip the dynamometer with as much strength as they can for 3 consecutive tries. The highest score will be their maximal voluntary contraction (MVC). The subject then rests for 60 seconds. The subject is asked to try to maintain 70% of their MVC and the duration the subject is able to maintain above 50% of their MVC is recorded. Immediately after the maintenance test, the subject performs three more MVCs and each one is recorded. These results are the duration the subject is able to maintain above 50% of their MVC.
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [seconds]	-9.08	-8.36

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.82
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	2.27
	Confidence Interval	(2-Sided) 95%; -17.59 to 22.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 10.02
	Estimation Comments

8. Other Pre-specified Outcome

Title	Parkinson's Disease Sleep Scale (PDSS)
Description	The Parkinson's disease sleep scale (PDSS) is a 15-item visual analogue scale that assesses the profile of nocturnal disturbances in Parkinson's disease patients. The severity of symptoms of sleep over the past week is marked with a cross along a 10 cm line (labeled worst to best state). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptom severe and always experienced) to 10 (symptom-free). The maximum score for PDSS is 150.
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [units on a scale]	-13.46	.64

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-4.73
	Confidence Interval	(2-Sided) 95%; -19.31 to 9.85
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 7.36
	Estimation Comments

9. Other Pre-specified Outcome

Title	Marin Apathy Inventory (Apathy Evaluation Scale)
Description	The Marin Apathy Inventory (Apathy Evaluation Scale) is a 14-item inventory measuring apathy of the subject over the past 2 to 4 weeks. Subjects are instructed to choose an answer from 0 to 3: 0=not at all, 1 = slightly, 2 = some, 3 = a lot, to questions related to apathy. The range would be 0 to 42, the higher the score the worse the apathy.
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [units on a scale]	.23	.46

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.93
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95%; -2.15 to 2.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.14
	Estimation Comments

10. Other Pre-specified Outcome

Title	Visual Analog Scale - Subset: Afraid
Description	The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [units on a scale]	-.77	-.83

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.82
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 95%; -1.05 to 0.83
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.47
	Estimation Comments

11. Other Pre-specified Outcome

Title	State-Trait Anxiety Inventory (STAI)
Description	The State-Trait Anxiety Inventory (STAI) is 40-item psychological inventory based on a 4-point Likert scale. Higher scores are positively correlated with higher levels of anxiety. The range for this test is 0 to 160.
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [units on a scale]	3.62	6.08

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.56
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-4.53
	Confidence Interval	(2-Sided) 95%; -19.74 to 10.69
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 7.68
	Estimation Comments

12. Other Pre-specified Outcome

Title	Becks Depression Inventory (BDI-II)
Description	The Becks Depression Inventory (BDI-II) is a 21-question inventory measuring the severity of depression. Each subject is instructed to choose an answer on a scale value of 0 to 3 with the total score from 0 to 63. Higher total scores indicate more severe depressive symptoms.
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	16	14
Mean (95% Confidence Interval) [units on a scale]	3.69	2.31

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-2.21
	Confidence Interval	(2-Sided) 95%; -8.02 to 3.59
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.93
	Estimation Comments

13. Other Pre-specified Outcome

Title	Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)
Description	Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)is a 14-question inventory measuring the motor functions of patients with Parkinson's Disease. Each subject is rated on a scale of 0 to 4 with the total score from 0 to 56. Higher total scores indicate more impairment of motor function.
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [units on a scale]	7.5	-0.83

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.58
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	2.76
	Confidence Interval	(2-Sided) 95%; -7.02 to 12.55
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.94
	Estimation Comments

14. Other Pre-specified Outcome

Title	Visual Analog Scale - Subset: Confused
Description	The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [units on a scale]	-.35	-.21

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.95
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; -1.04 to 1.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.54
	Estimation Comments

15. Other Pre-specified Outcome

Title	Visual Analog Scale - Subset: Sad
Description	The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [units on a scale]	-.19	-.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.48
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.38
	Confidence Interval	(2-Sided) 95%; -1.45 to 0.69
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.54
	Estimation Comments

16. Other Pre-specified Outcome

Title	Visual Analog Scale - Subset: Angry
Description	The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [units on a scale]	.19	.33

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.84
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 95%; -0.71 to 0.58
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.33
	Estimation Comments

17. Other Pre-specified Outcome

Title	Visual Analog Scale - Subset: Energetic
Description	The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [units on a scale]	-1.19	-2.12

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 95%; -0.77 to 1.76
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.64
	Estimation Comments

18. Other Pre-specified Outcome

Title	Visual Analog Scale - Subset: Tired
Description	The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [units on a scale]	.04	.75

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.33
	Confidence Interval	(2-Sided) 95%; -2.06 to 1.41
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.88
	Estimation Comments

19. Other Pre-specified Outcome

Title	Visual Analog Scale - Subset: Happy
Description	The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	15	14
Mean (95% Confidence Interval) [units on a scale]	.04	-0.33

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 95%; -0.62 to 1.90
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.64
	Estimation Comments

20. Other Pre-specified Outcome

Title	Visual Analog Scale - Subset: Tense
Description	The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).
Time Frame	Change from baseline to week 12

Outcome Measure Data

Analysis Population Description

The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.

Arm/Group Title	Rasagiline	Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.	Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Measure Participants	14	14
Mean (95% Confidence Interval) [units on a scale]	.25	.83

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rasagiline, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.94
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95%; -1.68 to 1.56
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.82
	Estimation Comments

Adverse Events

Arm/Group Title	Rasagiline		Sugar Pill
Arm/Group Description	Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. Rasagiline : Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.		Placebo tablet, 1 per day, duration is approximately 12 weeks. Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
All Cause Mortality
	Rasagiline		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Rasagiline		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/16 (6.3%)		0/14 (0%)
Nervous system disorders
Transient ischemic attack	1/16 (6.3%)	1	0/14 (0%)	0
Other (Not Including Serious) Adverse Events
	Rasagiline		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/16 (56.3%)		5/14 (35.7%)
Gastrointestinal disorders
nausea	1/16 (6.3%)	1	1/14 (7.1%)	2
Gastrointestinal disorders - other, diverticulitis	1/16 (6.3%)	1	0/14 (0%)	0
General disorders
fatigue	1/16 (6.3%)	1	1/14 (7.1%)	1
Fever	1/16 (6.3%)	1	0/14 (0%)	0
gait disturbance	1/16 (6.3%)	1	0/14 (0%)	0
Infections and infestations
skin infection	1/16 (6.3%)	1	0/14 (0%)	0
urinary tract infection	0/16 (0%)	0	2/14 (14.3%)	2
upper respiratory infection	2/16 (12.5%)	2	0/14 (0%)	0
Injury, poisoning and procedural complications
fall	1/16 (6.3%)	1	0/14 (0%)	0
injury, poisoning and procedureal complications, other - skin laceration	1/16 (6.3%)	1	0/14 (0%)	0
Musculoskeletal and connective tissue disorders
exostosis foot	1/16 (6.3%)	1	0/14 (0%)	0
myalgia	1/16 (6.3%)	1	0/14 (0%)	0
arthralgia	0/16 (0%)	0	1/14 (7.1%)	1
pain in extremity	0/16 (0%)	0	1/14 (7.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified, other - squamous cell carcinoma	1/16 (6.3%)	1	0/14 (0%)	0
Nervous system disorders
dizziness	1/16 (6.3%)	1	0/14 (0%)	0
Headache	1/16 (6.3%)	1	2/14 (14.3%)	3
paresthesia	0/16 (0%)	0	1/14 (7.1%)	1
extrapyramidal disorder	1/16 (6.3%)	1	0/14 (0%)	0
Psychiatric disorders
depression	1/16 (6.3%)	1	1/14 (7.1%)	1
insomnia	1/16 (6.3%)	1	0/14 (0%)	0
anxiety	0/16 (0%)	0	1/14 (7.1%)	1
Renal and urinary disorders
urinary urgency	0/16 (0%)	0	1/14 (7.1%)	1
urinary tract pain	0/16 (0%)	0	1/14 (7.1%)	1
Vascular disorders
hypertension	0/16 (0%)	0	1/14 (7.1%)	1
thrombolembolic event	1/16 (6.3%)	1	0/14 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.