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Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD) (CONFIDENT-PD)

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ClinicalTrials.gov Identifier: NCT01060878
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
Phytopharm

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson's Disease Drug: PYM50028 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 425 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale parts II & III combined score [ Time Frame: 28 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060878


Locations
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Sponsors and Collaborators
Phytopharm
More Information
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Responsible Party: Phytopharm
ClinicalTrials.gov Identifier: NCT01060878    
Other Study ID Numbers: P58/07CL/ST/09/02
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: March 2013
Keywords provided by Phytopharm:
Early-stage
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases