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

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

Tracking Information

• First Submitted Date: February 1, 2010
• First Posted Date: February 2, 2010
• Last Update Posted Date: March 4, 2013
• Study Start Date: November 2010
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 1, 2010): Unified Parkinson's Disease Rating Scale parts II & III combined score [ Time Frame: 28 Weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Parkinson's Disease

Intervention

• Drug: PYM50028
  IMP
• Drug: Placebo
  Matching placebo comprising identical vehicle to active doses

Study Arms

• Experimental: Dose I
  Intervention: Drug: PYM50028
• Experimental: Dose II
  Intervention: Drug: PYM50028
• Experimental: Dose III
  Intervention: Drug: PYM50028
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 11, 2012): 425
• Original Estimated Enrollment (submitted: February 1, 2010): 408
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Czech Republic, France, Germany, Hungary, Poland, Romania, Serbia, United Kingdom, United States

Administrative Information

• NCT Number: NCT01060878
• Other Study ID Numbers: P58/07CL/ST/09/02
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Phytopharm
• Study Sponsor: Phytopharm
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Phytopharm
• Verification Date: March 2013