PROOF-HD - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if an experimental drug called pridopine is a safe and effective treatment for Huntington's disease (HD).

For any questions about who can be in this study, please contact the study team at mckenzie.luxmore@duke.edu or 919-684-0865.

What is the Condition Being Studied?

Huntington's disease

Who Can Participate in the Study?

Adults 25 years of age and older who:
- Are diagnosed with adult-onset HD
- Have never used gene therapy
- Do not have epilepsy
- Have not had a seizure in the last 5 years

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomly assigned (like flipping a coin) to get the study drug or placebo (harmless, inactive substance)
- Take the study drug or placebo for 65 weeks (dosing period)
- Have 8 clinic visits
- Give blood and urine samples
- Have physical exams
- Answer questionnaires
- Have an electrocardiogram (ECG), a scan to look at your heart
- Have the option to extend your use of the study drug for 13 weeks at the end of the dosing period

Study Details

Full Title
PRidopidine Outcome On Function in Huntington Disease Patients (PROOF-HD)
Principal Investigator
Protocol Number
IRB: PRO00106811
NCT: NCT04556656
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698