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
  Purpose

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:


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 ]

Enrollment: 425
Study Start Date: November 2010
Study Completion Date: December 2012
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

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060878

  Show 111 Study Locations
Sponsors and Collaborators
Phytopharm
  More Information

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: March 1, 2013
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 July 23, 2014