Proof HD - A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease
Summary
This research is studying the medication pridopidine as a possible treatment for Huntington Disease (HD). The purpose of this research study is to:
• Evaluate the safety and effectiveness of the study drug, pridopidine.
• Evaluate the effect of pridopidine on everyday functioning and daily activities, as well as movement and behavior in participants with early stage Huntington Disease (HD).
• The study will last at least 65 weeks with a variable extension of up to additional 13 weeks.
• You will have 8 in-person study visits, 4 virtual visits (by telephone), and 6 telephone calls.
• At the end of the study, you may either have a 2 week follow-up period or an option to continue for an open-label extension. (OLE) This means that in the OLE study all participants would get the actual study drug and no participants would be getting the placebo
• The main activities in this study are assessments to measure:
o Your everyday functioning and daily activities
o Your general health, well-being and behavior
o Your movement, thinking and memory
o Your mood and the severity of depressions (if any), and your outlook about the future
o Your health and any problems since your last visit
o How your body takes in, distributes, and removes pridopidine
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 25 to 100
Inclusion criteria:
1. Male or female 25 years of age and older
2. Adult-onset HD with start of signs and symptoms at 18 years of age and older
3. Having mild HD symptoms like abnormal movements (chorea),
4. Able to read, write and speak English.
5. Females who are able to have children must have a negative pregnancy test at the first visit
Exclusion criteria:
You are not eligible to participate if you are:
1. Pregnant, planning to become pregnant, planning to father a child, or are breastfeeding a child.
2. Have heart disease that includes an abnormal rhythm of your heart (abnormal heart beat)
3. Have had epilepsy or seizures in the last 5 years
4. Have other serious medical illnesses that are not stable
5. Have a brain tumor or have had a stroke
6. Are taking medications that can cause an abnormal heartbeat
7. If you have had gene therapy
8. If you have abnormal kidney function
Participate
Additional information
Contact information
Lorelei Tainsh RN
Principal investigator:
Justyna Sarna
Clinical trial:
Yes
REB-ID:
REB20-1925