about the study
It is a Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)
Sponsor: Teva Pharmaceuticals
About the experimental drug
Pridopidine could have beneficial effects on the symptoms of the disease that depend on dopaminergic dysregulation. Dopamine is a substance naturally produced by the human body in various brain areas and has an impact on the way people behave, think and move. In preclinical studies it has been shown that Pridopidine appears to be able to strengthen synaptic transmission in the cortex and promotes the connection between important brain structures involved in Huntington's disease.
objective
The primary objective was to assess the safety and tolerability of the molecule Pridopidine in patients with Huntington's disease. The secondary objective was to evaluate the effects of the long-term dosage on motor symptoms, autonomy, physical performance, mood and behavior, quality of life in relation to health.
study sites
About 300 patients participated in this study in 46 centers in 12 states: Australia, Austria, Canada, Denmark, France, Germany, Italy, the Netherlands, Poland, Russia, the United Kingdom and the United States of America.
drug administration
The mode of administration is oral. One capsule should be taken in the morning and 1 in the afternoon, 7 to 10 hours after the morning dose.
inclusion criteria
- Pride HD completion within the last 6 months, including 2 week follow up period or patients who transitioned from the Open HART study or patients who complete future safety and efficacy clinical trials of pridopidine. In addition, patients who have already completed their defined study period under Open PRIDE HD global or local amendments and have discontinued treatment with pridopidine will be allowed to re enter the Open PRIDE HD study.
- Women of child bearing potential or male participants: Adequate contraception and birth control
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Good general health
Duration
From march 2015 to November 2017
With an amendment issued in July 2017, the study was to be extended for another 104 weeks, moving the deadline to 2019.
why was the study discontinued?
The pharmaceutical company Teva announced a sudden closure of the study in November 2017 after spreding the news of a 'phase 3' of the study.
Later TEVA announced a change in corporate strategy, which resulted in a divestment in the trials dedicated to the neurodegenerative field.
Many researchers and many patients have invested time and resources for many years towards the evidence of the effectiveness of this molecule.
The effects observed over the years on a global scale deserve further investigation.
