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A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)

A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease

NCT05107128•Supernus Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance and functioning in participants with HD.

Eligibility

Age

25 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Meet all the following criteria for HD at Screening (Days -28 to -2):
•1. Genetically confirmed disease with huntingtin gene CAG expansion greater than or equal to (≥) 36.
•2. At screening, Unified Huntington's Disease Rating Scale (UHDRS)-Total Functional Capacity (TFC) score greater than (\>) 6 and less than (\<)13, suggesting no more than a moderate level of functional impairment.
•3. No features of juvenile HD.
•2. Score of 15 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at screening indicating the presence of cognitive impairment.
•3. Be willing to invite a study partner, if available, who is reliable, competent, and at least 18 years of age to participate in the study.
•4. Be ambulatory (use of assistance devices such as a walker or cane is acceptable, as is occasional use of wheelchair, as judged by the investigator. Individuals requiring a wheelchair on a regular basis are excluded), able to travel to the study center, and, as judged by the investigator, is likely to be able to continue to travel to the study center to complete study visits for the duration of the study.
•5. Completion of Huntington's Disease Cognitive Assessment Battery (HD-CAB) Trail Making-B Test in less than 240 seconds at Screening (Days -28 to -2).

Exclusion Criteria

•1. Have participated in a previous clinical study of SAGE-718, have previous exposure to gene therapy, have participated in any HD investigational drug, biologic, or device trial within 180 days, or a non-HD drug, biologic, or device trial within 30 days or 5 half-lives (whichever is longer).
•(Note: Participants with confirmation of enrollment in the placebo arm of these trials would not be excluded.)
•2. Have a diagnosis of an ongoing neurodegenerative condition other than HD, including but not limited to Alzheimer's Disease, vascular dementia, dementia with Lewy bodies, or Parkinson's Disease.

Locations (49)

Sage Investigational Site

Little Rock, Arkansas, United States

Sage Investigational Site

La Jolla, California, United States

Sage Investigational Site

Los Angeles, California, United States

Sage Investigational Site

Sacramento, California, United States

Sage Investigational Site

Englewood, Colorado, United States

Sage Investigational Site

Washington D.C., District of Columbia, United States

Sage Investigational Site

Boca Raton, Florida, United States

Sage Investigational Site

Boca Raton, Florida, United States

Sage Investigational Site

Tampa, Florida, United States

Sage Investigational Site

Honolulu, Hawaii, United States

Key Dates

Start Date

January 26, 2022

Primary Completion Date

September 4, 2024

Completion Date

October 3, 2024

Last Updated

September 15, 2025

Enrollment

189

ACTUAL participants

Conditions

Huntington's Disease

Interventions

SAGE-718

DRUG

Placebo

DRUG

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

NCT02855476

Huntington's Disease

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ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease

NCT04120493

Huntington's Disease

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COMPLETEDPHASE1

Study to Measure Cerebrospinal Fluid Mutant Huntingtin Protein in Participants With Early Manifest Stage I or Stage II Huntington's Disease

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)

Inclusion Criteria

Exclusion Criteria

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease

Study to Measure Cerebrospinal Fluid Mutant Huntingtin Protein in Participants With Early Manifest Stage I or Stage II Huntington's Disease

A Study of Treatment With Pridopidine (ACR16) in Participants With Huntington's Disease

Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease

A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease