PRO-Go: Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)

• Sponsor: Supernus Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03944785
• Collaborator: (none)
• Enrollment: 164
• Locations: 30
• Actual Duration (Months): 25.3
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This is a Phase IV, prospective, observational, post-marketing study designed to obtain additional data on the effect of XADAGO on motor and non-motor symptoms in Parkinson's Disease patients newly prescribed XADAGO.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Parkinson Disease	Drug: XADAGO (safinamide)

Detailed Description

This Phase IV, multicenter, prospective, observational study to evaluate clinician-reported outcomes and patient-reported outcomes related to motor and non-motor symptoms, health status, quality of life and treatment satisfaction in PD patients who have been newly prescribed XADAGO according to Package Insert indication.

This study also will gather "real world" data from a PD population in the US regarding their overall experience and degree of satisfaction with the use of XADAGO as an add-on treatment to their L-dopa regimen. Treatment experience will be captured using patient self-rating assessments as well as clinician ratings on assessments.

Study Design

• Study Type: Observational
• Actual Enrollment: 164 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective, Observational Study to Evaluate Changes in Non-Motor Symptoms and Other Clinical Outcome Assessments of Parkinson's Disease Patients Treated With XADAGO (Safinamide)Tablets
• Actual Study Start Date: Nov 30, 2017
• Actual Primary Completion Date: Dec 23, 2019
• Actual Study Completion Date: Jan 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Parkinson's Disease Patients PD patients who have been newly prescribed safinamide (XADAGO) for the treatment of OFF episodes as described in the XADAGO Package Insert	Drug: XADAGO (safinamide); XADAGO (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes.; Other Names: XADAGO safinamide

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Baseline to Study Day 60]

   MDS-UPDRS: 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items; Score 0-52) examines non-motor experiences, Part II (13 items; Score 0-52) examines motor experiences, Part III (33 items; Score 0-132) examines the cardinal motor disabilities and Part IV (6 items; Score 0-24) examines motor complications. Each Part has 0-4 ratings, where 0 (no problems) to 4 (severe problems) and scores for each part are summed to calculate the total score which ranges from 0-260. Higher scores represent worse outcomes for each part and total score.

2. Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Scores [Baseline to Study Day 60]

   PDQ-39 is a patient-reported outcome designed to address aspects of functioning and well-being for those affected by PD. Each of the 39 items is rated using a 5 point Likert scale with 0 for never having difficulties/problems and 4 for always having difficulties/problems. The sum score of the 39 items will be calculated and used for analysis, with scores ranging from 0-156. Higher scores indicate worse outcomes.

3. Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score. [Baseline to Study Day 60]

   MoCA is a 30-point, 1-page test designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). The total score ranges from 0 to 30, with higher scores indicating better performances.

4. Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores [Study Day 60]

   TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions will be calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction.

5. Clinical Global Impression of Change (CGI-C) [Study Day 60]

   CGI-C is a 7-point scale depicting a Principal Investigator or certified Health Care Professional designee rating of the patient's overall improvement using a range of responses from a minimum of 1 (very much improved) to a maximum of 7 (very much worse).

6. Patient Global Impression of Change (PGI-C) [Study Day 60]

   PGI-C is a 7-point scale depicting a patient's rating of overall improvement using a range of responses from 1 (very much improved) to 7 (very much worse).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient (and Care Partner, if required per Inclusion Criterion 6) is able to understand and provide signed informed consent and HIPAA authorization in English.

2. Patient with diagnosis of idiopathic PD (all stages).

3. Independent of the study, clinician's and patient's choice of treatment is XADAGO in accordance with the Package Insert indication.

4. Patient is willing and able to participate in the study and complete study-related assessments for 2 months and, patients can continue for an optional 4-month study extension.

5. Patient has access to an electronic device for the interim completion of PROs.

6. Patient has an available Care Partner who is able and willing to assist with clinic attendance and completion of study assessments (e.g., PROs, health outcomes, etc.), if in the PI's opinion, assistance is needed to comply with all study visits and procedures.

Exclusion Criteria:

1. Any of the warnings, precautions, or contraindications listed in the XADAGO Package Insert that in the opinion of the PI would prevent appropriate treatment with XADAGO or impair study participation (e.g., pregnancy, lactation, severe hepatic impairment, etc.).

2. Participation in any other clinical trial of an investigational drug or device within 4 weeks prior to the Baseline Visit or at any time during the study.

3. Patient is currently receiving chemotherapy or radiation for any form of cancer (if history of cancer, must be in clinical remission at study entry) or currently receiving immunotherapy.

4. Patients with conditions that are likely to prevent them from accurately and reliably completing study assessments, including evidence of moderate or severe dementia as determined by the clinician (not to include mild cognitive impairment [MCI]); major psychiatric illness (specifically diagnosis of schizophrenia, bipolar disorder or a history of attempted suicide); and/or severe and progressive medical illness (including terminal cancer, end-stage renal disease +/- undergoing dialysis).

5. Severe or unpredictable dyskinesia at the time of the Baseline Visit.

6. Previous participation in this study; a patient may not re-enroll after prior discontinuation or completion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Neurology Associates	Homewood	Alabama	United States	35244
2	Movement Disorders Neurology, Inc.	Bakersfield	California	United States	93312
3	B.E.S.T. Center of Orange County	Laguna Hills	California	United States	92653
4	Valley Parkinson Clinic	Los Gatos	California	United States	95032
5	UC Davis Medical Center	Sacramento	California	United States	95817
6	Hartford Healthcare	Vernon	Connecticut	United States	06066
7	Georgetown University Hospital	Washington	District of Columbia	United States	20007
8	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida	United States	33486
9	Neuron Research	Naples	Florida	United States	34108
10	Parkinson's Disease Treatment Center of SW Florida	Port Charlotte	Florida	United States	33980
11	Sarasota Memorial Hospital Clinical Research Cener	Sarasota	Florida	United States	34239
12	Central DuPage Hospital	Winfield	Illinois	United States	60190
13	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
14	Baptist Health System	Richmond	Kentucky	United States	40475
15	Southeast Neuroscience Center, LLC	Gray	Louisiana	United States	70359
16	Lester and Cox Medical Center	Springfield	Missouri	United States	65807
17	Neurological Associates of Long Island, PC	Lake Success	New York	United States	11042
18	NYU Winthrop Hospital	Mineola	New York	United States	11501
19	FryeCare Neurology	Hickory	North Carolina	United States	28602
20	Dayton Center for Neurological Disorders	Centerville	Ohio	United States	45459
21	The Movement Disorder Clinic of Oklahoma	Tulsa	Oklahoma	United States	74137
22	Neurology and Stroke Associates	Lititz	Pennsylvania	United States	17543
23	Prisma Health	Greenville	South Carolina	United States	29615
24	Covenant Medical Group	Lubbock	Texas	United States	79410
25	Texas Institute for Neurological Disorders	Sherman	Texas	United States	75092
26	Houston Methodist - Sugar Land	Sugar Land	Texas	United States	77479
27	Baylor Scott and White Health	Temple	Texas	United States	76508
28	Inova Medical Group- Neurology I	Alexandria	Virginia	United States	22311
29	Meridian Clinical Research, LLC	Norfolk	Virginia	United States	23502
30	Puget Sound Neurology	Tacoma	Washington	United States	98409

Sponsors and Collaborators

• Supernus Pharmaceuticals, Inc.

Investigators

• Study Director: Bob James, PharmD, USWM, LLC (dba US WorldMeds)

Study Documents (Full-Text)

• Study Protocol - Oct 12, 2018
• Statistical Analysis Plan - Feb 8, 2020

More Information

Publications

None provided.

• Responsible Party: Supernus Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03944785
• Other Study ID Numbers: USWM-SA1-4001
• First Posted: May 10, 2019
• Last Update Posted: Jul 13, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Supernus Pharmaceuticals, Inc.: Parkinson's disease; Safinamide; Xadago; MAO-B inhibitor; off; non-motor symptoms; motor symptoms; levodopa; PD
• Additional relevant MeSH terms: Parkinson Disease

Study Results

Participant Flow

Arm/Group Title	DA Switchers	MAO-B Switchers	MAO-B Naive
Arm/Group Description	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor	Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
Period Title: 2 Month Study Completion
STARTED	2	34	128
COMPLETED	2	30	123
NOT COMPLETED	0	4	5
Period Title: 2 Month Study Completion
STARTED	1	10	64
COMPLETED	0	8	41
NOT COMPLETED	1	2	23

Baseline Characteristics

Arm/Group Title	DA Switchers	MAO-B	MAO-B Naive	Total
Arm/Group Description	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor	Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.	Total of all reporting groups
Overall Participants	2	34	128	164
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.5 (6.36)	65.3 (8.28)	68.1 (7.77)	67.4 (7.92)
Age, Customized (Count of Participants)
Age 30-65	1 50%	16 47.1%	39 30.5%	56 34.1%
Age >= 65	1 50%	18 52.9%	89 69.5%	108 65.9%
Sex: Female, Male (Count of Participants)
Female	0 0%	6 17.6%	43 33.6%	49 29.9%
Male	2 100%	28 82.4%	85 66.4%	115 70.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	6 4.7%	6 3.7%
Not Hispanic or Latino	2 100%	34 100%	122 95.3%	158 96.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	3 8.8%	4 3.1%	7 4.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	1 2.9%	1 0.8%	2 1.2%
White	2 100%	30 88.2%	121 94.5%	153 93.3%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	2 1.6%	2 1.2%
Height (cm) (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	179.6 (6.51)	173.1 (11.67)	171.0 (11.91)	171.6 (11.83)
Weight (kg) (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	96.2 (0.64)	85.0 (16.95)	88.1 (22.60)	87.6 (21.42)
BMI (kg/m^2) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.9 (2.36)	28.4 (5.17)	30.1 (7.05)	29.7 (6.68)
Movement Disorders Society - Unified Parkinson's Disease Rating Scale (units on a scale) [Mean (Standard Deviation) ]
Part 1	12.0 (2.83)	10.5 (6.32)	12.3 (6.88)	11.9 (6.75)
Part 2	7.0 (4.24)	11.8 (9.21)	13.8 (8.66)	13.3 (8.75)
Part 3	24.0 (2.83)	23.4 (14.13)	30.0 (26.0)	28.7 (15.95)
Part 4	3.0 (0.00)	5.3 (3.81)	4.5 (4.04)	4.6 (3.98)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Description	MDS-UPDRS: 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items; Score 0-52) examines non-motor experiences, Part II (13 items; Score 0-52) examines motor experiences, Part III (33 items; Score 0-132) examines the cardinal motor disabilities and Part IV (6 items; Score 0-24) examines motor complications. Each Part has 0-4 ratings, where 0 (no problems) to 4 (severe problems) and scores for each part are summed to calculate the total score which ranges from 0-260. Higher scores represent worse outcomes for each part and total score.
Time Frame	Baseline to Study Day 60

Outcome Measure Data

Analysis Population Description

Overall Number of Participants Analyzed represented by initial number analyzed at study visit Day 60; Number may differ for each Part (1-4) due to availability of score data. Evaluable Population: all subjects in the safety population who complete at least the MDS-UPDRS assessment at the Study Day 60 visit. Evaluable population will be used to analyze MDS-UPDRS endpoint.

Arm/Group Title	DA Switchers	MAO-B Switchers	MAO-B Naive
Arm/Group Description	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor	Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
Measure Participants	2	28	120
Part 1	-5.0 (5.66)	-1.0 (5.13)	-1.9 (6.16)
Part 2	0.0 (2.83)	-2.3 (5.40)	-2.6 (5.28)
Part 3	1.5 (2.12)	-3.3 (7.78)	-4.5 (11.10)
Part 4	-0.5 (3.54)	-0.3 (3.28)	-0.2 (3.05)

2. Primary Outcome

Title	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Scores
Description	PDQ-39 is a patient-reported outcome designed to address aspects of functioning and well-being for those affected by PD. Each of the 39 items is rated using a 5 point Likert scale with 0 for never having difficulties/problems and 4 for always having difficulties/problems. The sum score of the 39 items will be calculated and used for analysis, with scores ranging from 0-156. Higher scores indicate worse outcomes.
Time Frame	Baseline to Study Day 60

Outcome Measure Data

Analysis Population Description

Overall Number of Participants Analyzed represented by number analyzed at study visit Day 60. Safety Population: all subjects who sign informed consent form, complete baseline assessments, receive at least 1 dose of XADAGO. Safety population used to analyze all efficacy endpoints except MDS-UPDRS.

Arm/Group Title	DA Switchers	MAO-B Switchers	MAO-B Naive
Arm/Group Description	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor	Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
Measure Participants	1	25	97
Mean (Standard Deviation) [score on a scale]	-1.8	0.5 (9.73)	-0.5 (9.90)

3. Primary Outcome

Title	Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score.
Description	MoCA is a 30-point, 1-page test designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). The total score ranges from 0 to 30, with higher scores indicating better performances.
Time Frame	Baseline to Study Day 60

Outcome Measure Data

Analysis Population Description

Overall Number of Participants Analyzed represented by number analyzed at study visit Day 60. Safety Population: all subjects who sign informed consent form, complete baseline assessments, receive at least 1 dose of XADAGO. Safety population used to analyze all efficacy endpoints except MDS-UPDRS.

Arm/Group Title	DA Switchers	MAO-B Switchers	MAO-B Naive
Arm/Group Description	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor	Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
Measure Participants	2	28	119
Mean (Standard Deviation) [score on a scale]	0.0 (1.41)	0.9 (2.41)	0.4 (2.45)

4. Primary Outcome

Title	Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
Description	TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions will be calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction.
Time Frame	Study Day 60

Outcome Measure Data

Analysis Population Description

Overall Number of Participants Analyzed represented by number analyzed at study visit Day 60. Safety Population: all subjects who sign informed consent form, complete baseline assessments, receive at least 1 dose of XADAGO. Safety population used to analyze all efficacy endpoints except MDS-UPDRS.

Arm/Group Title	DA Switchers	MAO-B Switchers	MAO-B Naive
Arm/Group Description	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor	Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
Measure Participants	1	25	99
Mean (Standard Deviation) [score on a scale]	56.0	38.9 (7.73)	41.0 (9.81)

5. Primary Outcome

Title	Clinical Global Impression of Change (CGI-C)
Description	CGI-C is a 7-point scale depicting a Principal Investigator or certified Health Care Professional designee rating of the patient's overall improvement using a range of responses from a minimum of 1 (very much improved) to a maximum of 7 (very much worse).
Time Frame	Study Day 60

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DA Switchers	MAO-B Switchers	MAO-B Naive
Arm/Group Description	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor	Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
Measure Participants	2	34	128
Very Much Improved	0 0%	1 2.9%	13 10.2%
Much Improved	1 50%	7 20.6%	29 22.7%
Minimally Improved	0 0%	10 29.4%	38 29.7%
No Change	1 50%	6 17.6%	31 24.2%
Minimally Worse	0 0%	2 5.9%	7 5.5%
Much Worse	0 0%	1 2.9%	3 2.3%
Very Much Worse	0 0%	0 0%	0 0%

6. Primary Outcome

Title	Patient Global Impression of Change (PGI-C)
Description	PGI-C is a 7-point scale depicting a patient's rating of overall improvement using a range of responses from 1 (very much improved) to 7 (very much worse).
Time Frame	Study Day 60

Outcome Measure Data

Analysis Population Description

Participants Analyzed does not match the Participant Flow because some patient data was not captured for the visit. Safety Population: all subjects who sign informed consent form, complete baseline assessments, receive at least 1 dose of XADAGO. Safety population used to analyze all efficacy endpoints except MDS-UPDRS.

Arm/Group Title	DA Switchers	MAO-B Switchers	MAO-B Naive
Arm/Group Description	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor	Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
Measure Participants	2	25	100
Very Much Improved	0 0%	1 2.9%	9 7%
Much Improved	2 100%	3 8.8%	25 19.5%
Minimally Improved	0 0%	9 26.5%	31 24.2%
No Change	0 0%	8 23.5%	30 23.4%
Minimally Worse	0 0%	2 5.9%	2 1.6%
Much Worse	0 0%	2 5.9%	2 1.6%
Very Much Worse	0 0%	0 0%	1 0.8%

Adverse Events

Time Frame	6 months
Arm/Group Title	DA Switchers		MAO-B Switchers		MAO-B Naive
Arm/Group Description	Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA)		Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor		Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve.
All Cause Mortality
	DA Switchers		MAO-B Switchers		MAO-B Naive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/34 (0%)		2/128 (1.6%)
Serious Adverse Events
	DA Switchers		MAO-B Switchers		MAO-B Naive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		2/34 (5.9%)		8/128 (6.3%)
Cardiac disorders
Myocardial infarction	0/2 (0%)		0/34 (0%)		1/128 (0.8%)
Palpitations	0/2 (0%)		0/34 (0%)		1/128 (0.8%)
Gastrointestinal disorders
Gastric ulcer	0/2 (0%)		0/34 (0%)		1/128 (0.8%)
Postoperataive ileus	0/2 (0%)		0/34 (0%)		1/128 (0.8%)
Injury, poisoning and procedural complications
Fall	0/2 (0%)		0/34 (0%)		1/128 (0.8%)
Pneumothorax traumatic	0/2 (0%)		0/34 (0%)		1/128 (0.8%)
Radius fracture	0/2 (0%)		0/34 (0%)		1/128 (0.8%)
Rib fracture	0/2 (0%)		0/34 (0%)		1/128 (0.8%)
Road traffic accident	0/2 (0%)		0/34 (0%)		1/128 (0.8%)
Traumatic haemothorax	0/2 (0%)		0/34 (0%)		1/128 (0.8%)
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome	0/2 (0%)		0/34 (0%)		1/128 (0.8%)
Nervous system disorders
Dysarthria	0/2 (0%)		1/34 (2.9%)		0/128 (0%)
Vascular disorders
Deep vein thrombosis	0/2 (0%)		0/34 (0%)		1/128 (0.8%)
Peripheral arterial occlusive disease	0/2 (0%)		1/34 (2.9%)		0/128 (0%)
Other (Not Including Serious) Adverse Events
	DA Switchers		MAO-B Switchers		MAO-B Naive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		8/34 (23.5%)		17/128 (13.3%)
Gastrointestinal disorders
Nausea	0/2 (0%)		3/34 (8.8%)		9/128 (7%)
Injury, poisoning and procedural complications
Fall	0/2 (0%)		2/34 (5.9%)		11/128 (8.6%)
Nervous system disorders
Dizziness	0/2 (0%)		2/34 (5.9%)		4/128 (3.1%)
Tremor	1/2 (50%)		1/34 (2.9%)		2/128 (1.6%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/2 (0%)		2/34 (5.9%)		2/128 (1.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.