Phase II safety and efficacy study of Cogane in early Parkinson's disease
Status: Open to Enrollment
Start Date: Jun 01 2011
End Date: OPEN
A Phase II, multi-centre, randomized, 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.
Dr. David Shprecher at the University of Utah Department of Neurology is enrolling participants for the Randomized, Double Blind, and Placebo-Controlled study of CoganeTM in early Parkinson’s disease. CoganeTM is being developed by Phytopharm plc (the “Sponsor”), a pharmaceutical company based in the United Kingdom. CoganeTM works by changing the brain’s production of proteins, called neurotrophic factors that help the survival, development and function of nerve cells. These proteins are produced naturally by the body to protect nerve cells. It is also possible that these proteins could slow or even reverse the progression of diseases caused by nerve damage, by rescuing these nerve cells. These changes may take several weeks to take effect. The purpose of this study is to find out if CoganeTM works (that is, can it improve the symptoms of Parkinson’s or prevent them from worsening), is safe and well tolerated in patients with early-stage Parkinson’s and to determine how the body deals with Cogane.
The following are definitions pertaining to this study:
Randomized Trial: A research trial usually involves comparing different treatments. In a trial, one group will get one treatment and another group will get a different treatment. In a “randomized trial” people are put in one group or the other by random chance. This means that a computer will decide by chance which group a person is in, not the doctors running the trial. Participants have a 3 in 4 (75%) chance of receiving CoganeTM, (for example: for every four patients recruited, three patients will receive CoganeTM one at the lowest dose, one at the middle dose, and one at the highest dose – and one patient will receive placebo) Double Blind Trial: In this trial, neither you nor your doctor will know which treatment group you are in (although, if your doctor needs to find out for important medical reasons, he/she can do so). If you receive study drug, the dose that you will be taking will be unknown to both you and the study doctor, although this information can be made available to your study doctor if necessary e.g. if you require emergency treatment.
Because we are testing the efficacy of CoganeTM we need to compare it to a placebo. A placebo: is a dummy treatment such as a liquid which looks like the liquid that contains the study drug but it is not. Placebos contain no drugs or active ingredients. Study participants are given placebos so that the effects of a drug can be compared against no drug. Use of placebos also prevents the participant and the doctor from knowing whether or not the subject is getting the drug.
This study is a Randomized, Double Blind, and Placebo-Controlled Trial. Participants will have a 3 out of 4 chance of being assigned to an active treatment (and a 1 out of 4 chance of being assigned a placebo (inactive) treatment.
In this study, the primary objectives are to determine whether CoganeTM exhibits clinical benefit in the treatment of participants with early-stage PD, as assessed by the Unified Parkinson’s Disease Rating Scale score for Parts II and III combined (UPDRS II/III), compared with placebo. The secondary objectives are to evaluate the efficacy of CoganeTM compared with placebo on other aspects of PD and to assess the safety, tolerability and plasma concentration of CoganeTM in the treatment of early stage PD.
Participants may be included in the study only if they meet all of the following criteria:
- Male or female between 35 and 75 years of age, inclusive at the time of consent.
- Participants must have a diagnosis of early-stage idiopathic PD within the 2 years prior to screening.
- Women must be of non-child bearing potential: post-menopausal or surgically sterile.
- Men must agree to use two medically acceptable methods of contraception throughout the study and for 1 month after completing it.
Participants will be excluded from the study for any of the following reasons:
- Participants who have had a neurosurgical procedure for PD.
- Participants currently taking any treatment for PD. Participants that have previously taken any medicinal treatment for PD for a total period not exceeding 4 weeks AND have not taken any medicinal treatment for PD within the 8 weeks prior to screening can be included in the study.
- Participants who are currently taking or who have taken Coenzyme Q10 at daily doses >300 mg, unless for a total period not exceeding 4 weeks and not within 12 weeks prior to screening.
- Participants receiving any of the following medications: St John’s Wort, digoxin, warfarin or heparin
- Females who are breast feeding, pregnant, or intending to become pregnant; male participants whose partner is intending to become pregnant.
Name: Maria North, Study Coordinator
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