A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Tolerability of Cogane (PYM50028)
WHAT IS THE TITLE OF THE STUDY?
A Phase II, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Tolerability of Cogane ™(PYM50028), a Novel, Orally Active Neurotrophic Factor Inducer, in Male and Female Subjects with Early-Stage Parkinson’s Disease When Administered Once Daily for 28 Weeks (Phytopharm)
WHAT IS THE PURPOSE OF THE STUDY?
The purpose of the study is to find out if Cogane™ works (that is, can it improve the symptoms of PD or prevent them from worsening), is safe and well tolerated in patients with early-stage PD and to determine how the body deals with Cogane™. The doses of the study drug that will be tested in this study are 60, 120, and 180 mg per day or a placebo. Subjects will have a 3 in 4 (75%) chance of receiving Cogane™ (for example: for every four subjects recruited, three patients will receive Cogane™ one at the lowest dose, one at the middle dose, and one at the highest dose – and one subject will receive placebo)
WHO IS NEEDED?
1) Subjects must have a confirmed diagnosis of early-stage idiopathic PD within the past 2 years and not currently taking treatment
2) Male or female subjects aged between 35 and 75 years
3) Female subjects must be of non-child bearing potential: post-menopausal
WHAT IS INVOLVED IF I PARTICIPATE?
Duration: The study will last 34 weeks
Tests/Procedures: physical exam and PD ratings, interviews, questionnaires, blood drawing, vital signs, EKG
Risks: Risks will be discussed with volunteers as part of the informed consent process.
Benefits: Participation might help future patients with PD.
WHO IS THE PRINCIPAL INVESTIGATOR (DOCTOR)?
Susan Criswell, M.D.
WHERE WILL THE STUDY TAKE PLACE?
Washington University School of Medicine
Contact Information:
Coordinator Name: Melissa Ammel
Tel: (314) 747-3470 Email: ammelm@neuro.wustl.edu
