NCT05358821

28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease

A 28-Day Randomized, Placebo-Controlled, Double-Blind, Parallel Groups and Normative Comparison Study to Evaluate the Effect of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to assess the magnitude of the baseline difference between participants with early Huntington's Disease (HD) and healthy participants (HP) with respect to measures of cognitive performance.

Conditions

• Huntington Disease

Interventions

Type	Name	Description
DRUG	SAGE-718	SAGE-718 oral softgel lipid capsules
DRUG	Placebo	SAGE-718-matching oral capsules

Timeline

• Start date: 2022-05-26
• Primary completion: 2024-02-29
• Completion: 2024-04-10
• First posted: 2022-05-03
• Last updated: 2025-09-15
• Results posted: 2025-05-06

Locations

14 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study