about the study
Pride - HD is a multicenter, multinational, randomized, parallel-group, double-blind, placebo-controlled, dose range finding study to compare the efficacy and safety of different doses of pridopidine versus placebo in the treatment of motor impairment in Huntington's Disease (HD).
Sponsor: Teva Pharmaceuticals
about the experimental drug
The investigational drug Pridopidine, was tested in its effect on some of the symptoms of Huntington’s Disease that depend on dopamine. Dopamine is a substance that is naturally made by the human body. It is made in many areas of the brain, and affects how people behave, think and move. It has been suggested that changes in the way dopamine works in Huntington’s Disease creates signs and symptoms of the condition.
Objective
The purpose of this randomized, double blind study was to see what effect the investigational drug, pridopidine, has on movement, thinking, and behavior, compared to placebo, in people with Huntington disease after 26 weeks of receiving either pridopidine or placebo. In addition, the aim was to collect information about safety and tolerability of pridopidine in people with HD, after 52 weeks of treatment.
study sites
408 participants were enrolled globally at approximately 51 study sites: 29 in Europe and 22 in the USA.
drug administration
The drug was administered orally: two capsules a day 7-10 hours one from the other. Different dosages of the drug were tested: 45 mg, 67.5 mg, 90 mg, 112.5 mg; each dosage refers to the mg contained in the single capsule.
what did it highlight?
The study did not provide the expected results regarding the objectives outlined. Despite this, exploratory analyzes have shown the efficacy of the molecule in improving autonomy, or at least in slowing down its decline compared to those who took placebo. This effect was even more evident in patients in the early stages of the disease.
duration:
Started in 2014 and finished in 2015.
The study moved on to a subsequent 'open' phase - in which all participants took the drug and none the placebo - called 'Open Pride'
