A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants with Huntington’s disease (HD).

Conditions

Huntington’s disease (HD).

Brief summary

1. Change from baseline to Week 52 in cUHDRS.

Detailed description

1. Change from baseline to Week 52 in functional capacity as measured by the Total Functional Capacity (TFC) score., 2. Change from baseline to Week 52 in motor function as measured by Quantitative Motor (Q-Motor) Finger Tapping Inter-onset Interval (FT-IOI) mean (Digitomotography)., 3. Change from baseline to Week 52 in cognition as measured by Stroop Word Reading (SWR)., 4. Incidence (count and rate) and nature of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) overall, by severity, by relationship to study drug, and those that led to discontinuation of study drug and/or withdrawal from the study.

Related papers

No related papers found yet.

Interventions

DRUGPridopidine placebo

DRUGPRIDOPIDINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Change from baseline to Week 52 in cUHDRS.	—

Secondary

Measure	Time frame
1. Change from baseline to Week 52 in functional capacity as measured by the Total Functional Capacity (TFC) score., 2. Change from baseline to Week 52 in motor function as measured by Quantitative Motor (Q-Motor) Finger Tapping Inter-onset Interval (FT-IOI) mean (Digitomotography)., 3. Change from baseline to Week 52 in cognition as measured by Stroop Word Reading (SWR)., 4. Incidence (count and rate) and nature of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) overall, by severity, by relationship to study drug, and those that led to discontinuation of study drug and/or withdrawal from the study.	—

Measure

Time frame

1. Change from baseline to Week 52 in functional capacity as measured by the Total Functional Capacity (TFC) score., 2. Change from baseline to Week 52 in motor function as measured by Quantitative Motor (Q-Motor) Finger Tapping Inter-onset Interval (FT-IOI) mean (Digitomotography)., 3. Change from baseline to Week 52 in cognition as measured by Stroop Word Reading (SWR)., 4. Incidence (count and rate) and nature of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) overall, by severity, by relationship to study drug, and those that led to discontinuation of study drug and/or withdrawal from the study.

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Outcome results

None listed