Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)
This study is ongoing, but not recruiting participants.
Sponsor:
Phytopharm
Information provided by (Responsible Party):
Phytopharm
ClinicalTrials.gov Identifier:
NCT01060878
First received: February 1, 2010
Last updated: April 18, 2012
Last verified: April 2012
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A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and well tolerated in this study and demonstrate therapeutic benefit in this patient population.
Condition | Intervention | Phase |
---|---|---|
Parkinson's Disease |
Drug: PYM50028 Drug: Placebo |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Official Title: | Phase II, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of PYM50028 in Subjects With Early-stage Parkinson's Disease Administered Once Daily for 28 Weeks |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial paroxysmal nonkinesigenic dyskinesia
Perry syndrome
MedlinePlus related topics:
Parkinson's Disease
U.S. FDA Resources
Further study details as provided by Phytopharm:
Primary Outcome Measures:
- Unified Parkinson's Disease Rating Scale parts II & III combined score [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: | 408 |
Study Start Date: | November 2010 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Dose I |
Drug: PYM50028
IMP
|
Experimental: Dose II |
Drug: PYM50028
IMP
|
Experimental: Dose III |
Drug: PYM50028
IMP
|
Placebo Comparator: Placebo |
Drug: Placebo
Matching placebo comprising identical vehicle to active doses
|
![](https://webarchive.library.unt.edu/web/20121019005710im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 35 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- confirmed diagnosis of early-stage idiopathic PD within the 2 years prior to screening
- subjects who are not currently receiving any PD treatment
Exclusion Criteria:
- female of child-bearing potential
- history of neurosurgical procedures for PD
- history of severe psychiatric illness
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01060878
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Sponsors and Collaborators
Phytopharm
![](https://webarchive.library.unt.edu/web/20121019005710im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Phytopharm |
ClinicalTrials.gov Identifier: | NCT01060878 History of Changes |
Other Study ID Numbers: | P58/07CL/ST/09/02 |
Study First Received: | February 1, 2010 |
Last Updated: | April 18, 2012 |
Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Phytopharm:
Early-stage |
Additional relevant MeSH terms:
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on October 17, 2012