The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease

• Sponsor: Huashan Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01470859
• Collaborator: Boehringer Ingelheim (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Levodopa and non-ergot dopaminergic agonists such as pramipexole are both recommended as the first-line symptomatic treatment for early untreated Parkinson's disease (PD), previous clinical trial indicated that initial pramipexole owns advantage over levodopa regarding motor complications, on the contrary, less adverse effect like freezing and severe somnolence favors initial treatment of levodopa. Thus, it remains controversial that initiation of which medication will be better for those patients with early PD.

Parkinson's disease-related spatial covariance patter (PDRP) is a new biomarker which can represent the network activity of brain and severity of PD. Based on the literatures and our previous data, the investigators hypothesize that PDRP will be served as a biomarker to help us evaluate and compare the effect of levodopa or pramipexole on the progression of PD, which might be able to provide further evidence for clinicians to address the above critical issue.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Parkinson's Disease	Drug: pramipexole; Drug: Sinemet CR	N/A

Detailed Description

CALM-PD study found that Pramipexole can reduce the occurrence of motor complication compared with Levodopa used as initiative treatment, but it still remains debatable that initiation of which medication will be better for those patients with De Novo PD.

PDRP (Parkinson's disease-related spatial covariance pattern) is a biomarker which can represent the network activity of cortico-striato-pallido-thalamocortical pathways and highly reproducible with stable network activity in individual subjects. The study published in "J Neuroscience" in 2010 showed that the abnormal PDRP antecede the appearance of motor signs by about 2 years, indicating PDRP might be a very promising biomarker for identifying PD at its early stage. Moreover, PDRP is able to represent the progression and severity of PD as well. It was reported that Levodopa can reduce the PD-related network activity, and the degree of network suppression correlates with the clinical improvement. However, there is no study currently showing the impact of pramipexole on brain PDRP network compared with levodopa as initiative treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: a Pilot Follow-up Study of Investigating the Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Chinese Patients With Early Parkinson's Disease
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: pramipexole 0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients	Drug: pramipexole; tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.; Other Names: Sifrol
Active Comparator: Levodopa Sinemet CR CR， Controlled Release	Drug: Sinemet CR; tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year; Other Names: Sinemet CR 250' (Levodopa 200mg, and 50mg carbidopa)

Outcome Measures

Primary Outcome Measures

1. Longitudinal Change of Brain Network Activity [twice, baseline and 1 year after baseline]

   The brain network activity is evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value (Z score). The change of brain network activity is calculated by the PDRP value (Z score) at V5 - the PDRP value (Z score) at V1.

Secondary Outcome Measures

1. Unified Parkinson's Disease Rating Score (UPDRS II, III) [three times: baseline, 10 weeks, 1 year]

   baseline (1st visit, V1), completion of dosage titration within 10 weeks after baseline (2nd visit, V2), 1 year after baseline (final visit, V5) UPDRS II score 0-52 (13 items); UPDRS III score 0-56 (14 items); The more scores,the more severe; the two scales were evaluated separately.

2. Parkinson's Disease Questionnaire (PDQ39) [twice baseline and 1 year]

   The PDQ39 score was assessed at baseline (1st visit, V1) and 1 year after baseline (final visit, V5). PDQ39 score ranges from 0-156 (0-4 each item); the more score, the more severe.

3. Hoehn&Yahr (H&Y) Staging [twice baseline and 1 year]

   The Hoehn and Yahr scale is a commonly used scale for describing how the symptoms of Parkinson's disease progress and the disease stages. Bigger numbers indicate more symptoms and disease progression. H&Y stage range from 0-5; the greater, the more severe. The H&Y stages of patients were evaluated at baseline (1st visit, V1), and 1 year after baseline (final visit, V5).

4. Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI). [twice, at 10 weeks(V2) and 1 year(V5)]

   Patients with a score <= 2 (very much or much improved in relation to baseline) are considered as clinically improved. The numbers of participants with clinical improvement are reported here. The completion of dosage titration within 10 weeks after baseline (visit 2) and 1 year after baseline (final visit)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• idiopathic Parkinson's disease meeting United Kingdom (UK) brain bank criteria

• De Novo

• Hoehn&Yahr staging (H&Y) I-II

Exclusion Criteria:

• Atypical Parkinsonism

• Pregnant or breast-feeding women

• those with abnormal Liver/kidney function

• those participating other clinical trials within 30 days before being enrolled for this trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai	China	200040

Sponsors and Collaborators

• Huashan Hospital
• Boehringer Ingelheim

Investigators

• Principal Investigator: Jian Wang, MD, Huashan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Huang C, Tang C, Feigin A, Lesser M, Ma Y, Pourfar M, Dhawan V, Eidelberg D. Changes in network activity with the progression of Parkinson's disease. Brain. 2007 Jul;130(Pt 7):1834-46. Epub 2007 Apr 30.
• Izumi Y, Sawada H, Yamamoto N, Kume T, Katsuki H, Shimohama S, Akaike A. Novel neuroprotective mechanisms of pramipexole, an anti-Parkinson drug, against endogenous dopamine-mediated excitotoxicity. Eur J Pharmacol. 2007 Feb 28;557(2-3):132-40. Epub 2006 Nov 14.
• Ma Y, Tang C, Spetsieris PG, Dhawan V, Eidelberg D. Abnormal metabolic network activity in Parkinson's disease: test-retest reproducibility. J Cereb Blood Flow Metab. 2007 Mar;27(3):597-605. Epub 2006 Jun 28.
• Parkinson Study Group. A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: the PRESTO study. Arch Neurol. 2005 Feb;62(2):241-8.
• Tang CC, Poston KL, Dhawan V, Eidelberg D. Abnormalities in metabolic network activity precede the onset of motor symptoms in Parkinson's disease. J Neurosci. 2010 Jan 20;30(3):1049-56. doi: 10.1523/JNEUROSCI.4188-09.2010.
• Wang J, Ma Y, Huang Z, Sun B, Guan Y, Zuo C. Modulation of metabolic brain function by bilateral subthalamic nucleus stimulation in the treatment of Parkinson's disease. J Neurol. 2010 Jan;257(1):72-8. doi: 10.1007/s00415-009-5267-3. Epub 2009 Aug 7.

• Responsible Party: Jian Wang, Professor, Huashan Hospital
• ClinicalTrials.gov Identifier: NCT01470859
• Other Study ID Numbers: KY2011-283
• First Posted: Nov 11, 2011
• Last Update Posted: Oct 21, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Jian Wang, Professor, Huashan Hospital: De Novo parkinson's disease; initial treatment; pramipexole; Levodopa; Parkinson's disease-related spatial covariance pattern
• Additional relevant MeSH terms: Parkinson Disease; Levodopa; Carbidopa; Pramipexole; Carbidopa, levodopa drug combination

Study Results

Participant Flow

Arm/Group Title	Levodopa	Pramipexole
Arm/Group Description	Sinemet Controlled Release (CR) Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year	0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
Period Title: Overall Study
STARTED	15	15
COMPLETED	14	15
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Pramipexole	Levodopa	Total
Arm/Group Description	0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.	Sinemet CR Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year	Total of all reporting groups
Overall Participants	15	14	29
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.87 (5.68)	61.9 (6.66)	62.9 (6.14)
Sex: Female, Male (Count of Participants)
Female	7 46.7%	8 57.1%	15 51.7%
Male	8 53.3%	6 42.9%	14 48.3%
Region of Enrollment (participants) [Number]
China	15 100%	14 100%	29 100%

Outcome Measures

1. Primary Outcome

Title	Longitudinal Change of Brain Network Activity
Description	The brain network activity is evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value (Z score). The change of brain network activity is calculated by the PDRP value (Z score) at V5 - the PDRP value (Z score) at V1.
Time Frame	twice, baseline and 1 year after baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Levodopa	Pramipexole
Arm/Group Description	Sinemet CR Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year	0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
Measure Participants	14	15
Change from baseline (V5-V1)	0.41 (0.70)	0.61 (0.68)
Z score at baseline (V1)	2.21 (1.54)	3.61 (1.77)
Z score at 1 year (V5)	2.29 (1.24)	4.09 (1.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.84
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	t-test, 2 sided
	Comments	independent sample t-test The statistical analysis was performed on the changes of PDRP Z score between levodopa and pramipexole groups.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.93
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	t-test, 2 sided
	Comments	independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V1

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	t-test, 2 sided
	Comments	independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V5

2. Secondary Outcome

Title	Unified Parkinson's Disease Rating Score (UPDRS II, III)
Description	baseline (1st visit, V1), completion of dosage titration within 10 weeks after baseline (2nd visit, V2), 1 year after baseline (final visit, V5) UPDRS II score 0-52 (13 items); UPDRS III score 0-56 (14 items); The more scores,the more severe; the two scales were evaluated separately.
Time Frame	three times: baseline, 10 weeks, 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Levodopa	Pramipexole
Arm/Group Description	Sinemet CR Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year	0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
Measure Participants	14	15
UPDRS II at baseline (V1)	7.3 (3.5)	7.1 (2.9)
UPDRS II (V2)	5.8 (3.5)	4.9 (3.3)
UPDRS II at 1 year (V5)	7.4 (3.5)	8.4 (3.0)
UPDRS III at baseline (V1)	18.7 (7.7)	23.1 (10.4)
UPDRS III (V2)	12.7 (4.2)	20.1 (8.9)
UPDRS III at 1 year (V5)	19.5 (7.0)	24.3 (8.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.691
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	independent U test
	Comments	independent U test The statistical analysis was performed to compare the UPDRS II scores at V1 scores between the levodopa and pramipexole groups

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.706
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	independent U test
	Comments	independent U test The statistical analysis was performed to compare the UPDRS II scores at V2 scores between the levodopa and pramipexole groups

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.635
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	independent U test
	Comments	independent U test The statistical analysis was performed to compare the UPDRS II scores at V5 scores between the levodopa and pramipexole groups

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.341
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	independent U test
	Comments	independent U test The statistical analysis was performed to compare the UPDRS III scores at V1 scores between the levodopa and pramipexole groups

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.049
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	independent U test
	Comments	independent U test The statistical analysis was performed to compare the UPDRS III scores at V2 scores between the levodopa and pramipexole groups

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.874
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	independent U test
	Comments	independent U test The statistical analysis was performed to compare the UPDRS III scores at V5 scores between the levodopa and pramipexole groups

3. Secondary Outcome

Title	Parkinson's Disease Questionnaire (PDQ39)
Description	The PDQ39 score was assessed at baseline (1st visit, V1) and 1 year after baseline (final visit, V5). PDQ39 score ranges from 0-156 (0-4 each item); the more score, the more severe.
Time Frame	twice baseline and 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Levodopa	Pramipexole
Arm/Group Description	Sinemet CR Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year	0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
Measure Participants	14	15
PDQ39 at baseline (V1)	19.38 (10.94)	20.36 (16.49)
PDQ39 at 1 year (V5)	20.36 (16.49)	21.07 (12.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.720
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	independent U test
	Comments	independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V1

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.867
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	independent U test
	Comments	independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V5

4. Secondary Outcome

Title	Hoehn&Yahr (H&Y) Staging
Description	The Hoehn and Yahr scale is a commonly used scale for describing how the symptoms of Parkinson's disease progress and the disease stages. Bigger numbers indicate more symptoms and disease progression. H&Y stage range from 0-5; the greater, the more severe. The H&Y stages of patients were evaluated at baseline (1st visit, V1), and 1 year after baseline (final visit, V5).
Time Frame	twice baseline and 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Levodopa	Pramipexole
Arm/Group Description	Sinemet CR Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year	0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
Measure Participants	14	15
H&Y at baseline（V1）	1.35 (0.42)	1.43 (0.51)
H&Y at 1 year（V5）	1.65 (0.47)	1.82 (0.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.793
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	indenpendent U test
	Comments	independent U test The statistical analysis was performed to compare the H&Y stages between levodopa and pramipexole group at V1

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.430
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	independent U test
	Comments	independent U test The statistical analysis was performed to compare the H&Y stages between levodopa and pramipexole groups at V5

5. Secondary Outcome

Title	Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).
Description	Patients with a score <= 2 (very much or much improved in relation to baseline) are considered as clinically improved. The numbers of participants with clinical improvement are reported here. The completion of dosage titration within 10 weeks after baseline (visit 2) and 1 year after baseline (final visit)
Time Frame	twice, at 10 weeks(V2) and 1 year(V5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Levodopa	Pramipexole
Arm/Group Description	Sinemet CR Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year	0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
Measure Participants	14	15
Patients with improvement at V2	6 40%	4 28.6%
Patients with improvement at V5	2 13.3%	4 28.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.345
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	Chi-squared
	Comments	The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V2

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Levodopa, Pramipexole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.410
	Comments	"p<0.05" is indicating the threshold for statistical significance for this comparison
	Method	Chi-squared
	Comments	The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V5

Adverse Events

Time Frame	1 years
Arm/Group Title	Levodopa		Pramipexole
Arm/Group Description	Sinemet CR Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year		0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
All Cause Mortality
	Levodopa		Pramipexole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Levodopa		Pramipexole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Levodopa		Pramipexole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/14 (28.6%)		2/15 (13.3%)
Gastrointestinal disorders
Gastritis	1/14 (7.1%)		0/15 (0%)
Musculoskeletal and connective tissue disorders
Courbature	1/14 (7.1%)		0/15 (0%)
Nervous system disorders
Somnolence	0/14 (0%)		2/15 (13.3%)
Insomnia	1/14 (7.1%)		0/15 (0%)
Dizziness	1/14 (7.1%)		0/15 (0%)

Limitations/Caveats

In the further study, a larger sample size and strict enrollment of early PD patients may enhance the accuracy of clinical trial conclusions.

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.