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

History of Changes

Tracking Information
First Received Date ^ICMJE	February 1, 2010
Last Updated Date	March 1, 2013
Start Date ^ICMJE	November 2010
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 1, 2010)	Unified Parkinson's Disease Rating Scale parts II & III combined score [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01060878 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Parkinson's Disease
Intervention ^ICMJE	Drug: PYM50028 IMP Drug: Placebo Matching placebo comprising identical vehicle to active doses
Study Arm (s)	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
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	425
Completion Date	December 2012
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	35 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada, Czech Republic, France, Germany, Hungary, Poland, Romania, Serbia, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01060878
Other Study ID Numbers ^ICMJE	P58/07CL/ST/09/02
Has Data Monitoring Committee	Yes
Responsible Party	Phytopharm
Study Sponsor ^ICMJE	Phytopharm
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Phytopharm
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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