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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Phytopharm
ClinicalTrials.gov Identifier:
NCT01060878
First received: February 1, 2010
Last updated: March 1, 2013
Last verified: March 2013

February 1, 2010
March 1, 2013
November 2010
December 2012   (final data collection date for primary outcome measure)
Unified Parkinson's Disease Rating Scale parts II & III combined score [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01060878 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: PYM50028
    IMP
  • Drug: Placebo
    Matching placebo comprising identical vehicle to active doses
  • Experimental: Dose I
    Intervention: Drug: PYM50028
  • Experimental: Dose II
    Intervention: Drug: PYM50028
  • Experimental: Dose III
    Intervention: Drug: PYM50028
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
425
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Poland,   Romania,   Serbia,   United Kingdom
 
NCT01060878
P58/07CL/ST/09/02
Yes
Phytopharm
Phytopharm
Not Provided
Not Provided
Phytopharm
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP