We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01060878
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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

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
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
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

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


  Show 111 Study Locations
Sponsors and Collaborators
Phytopharm
More Information

Responsible Party: Phytopharm
ClinicalTrials.gov Identifier: NCT01060878     History of Changes
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:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases