Pridopidine's Outcome On Function In Huntington Disease, Proof- Hd
Posted Date: Apr 30, 2021
- Investigator: Andrew Duker
- Specialties: Movement Disorders, Neurology
- Type of Study: Drug
This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pridopidine 45 mg BID in patients with early stage HD. Eligible patients who completed the Main Study (65 to 78 weeks) will have the option to enroll into an open-label extension.
To Be Eligible For This Study, You Must Have A Diagnosis Of Hd Based On Clinical Features And The Presence Of =36 Cag Repeats In The Huntingtin Gene. Adult-Onset Hd With Onset Of Signs And Symptoms =18 Years Of Age. Stage 1 Or Stage 2 Hd, Defined As A Uhdrs-Tfc Score Of =7, At Screening. To Be Eligible, You Must Not Have Use Of Pridopidine Within 12 Months Before The Baseline Visit. Gene Therapy At Any Time. Any Serious Medical Condition Or Clinically Significant Laboratory, Or Vital Sign Abnormality That Precludes The Patient's Safe Participation In And Completion Of The Study E.G. Significant Heart Disease Within 12 Weeks Before Baseline Or History Of Certain Cardiac Arrhythmias. History Of Epilepsy Or Seizures Within The Last 5 Years. Pregnant Or Breastfeeding, Or Intention To Become Pregnant During The Study.
Huntington's Disease, Neurology, Duker
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