A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)
NCT ID: NCT05107128
Last Updated: 2025-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
189 participants
INTERVENTIONAL
2022-01-26
2024-10-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants will receive SAGE-718-matching placebo, orally, once daily (QD) for up to Day 84.
Placebo
SAGE-718-matching oral capsules.
SAGE-718
Participants will receive SAGE-718, 1.2 milligrams (mg), capsules, orally, QD for Days 1 to 27, followed by 0.9 mg for the remainder of the treatment period up to Day 84.
SAGE-718
Oral capsules.
Interventions
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SAGE-718
Oral capsules.
Placebo
SAGE-718-matching oral capsules.
Eligibility Criteria
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Inclusion Criteria
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
(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.
25 Years
65 Years
ALL
No
Sponsors
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Supernus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Sage Investigational Site
Chicago, Illinois, United States
Sage Investigational Site
Chicago, Illinois, United States
Sage Investigational Site
Indianapolis, Indiana, United States
Sage Investigational Site
Iowa City, Iowa, United States
Sage Investigational Site
Kansas City, Kansas, United States
Sage Investigational Site
Baltimore, Maryland, United States
Sage Investigational Site
Boston, Massachusetts, United States
Sage Investigational Site
Boston, Massachusetts, United States
Sage Investigational Site
Farmington Hills, Michigan, United States
Sage Investigational Site
Buffalo, New York, United States
Sage Investigational Site
New York, New York, United States
Sage Investigational Site
Chapel Hill, North Carolina, United States
Sage Investigational Site
Durham, North Carolina, United States
Sage Investigational Site
Cincinnati, Ohio, United States
Sage Investigational Site
Toledo, Ohio, United States
Sage Investigational Site
Philadelphia, Pennsylvania, United States
Sage Investigational Site
Charleston, South Carolina, United States
Sage Investigational Site
Memphis, Tennessee, United States
Sage Investigational Site
Nashville, Tennessee, United States
Sage Investigational Site
Houston, Texas, United States
Sage Investigational Site
Richmond, Virginia, United States
Sage Investigational Site
Kirkland, Washington, United States
Sage Investigational Site
Spokane, Washington, United States
Sage Investigational Site
Madison, Wisconsin, United States
Sage Investigational Site
Westmead, New South Wales, Australia
Sage Investigational Site
Herston, Queensland, Australia
Sage Investigational Site
Bethlehem, Victoria, Australia
Sage Investigational Site
Nedlands, Western Australia, Australia
Sage Investigational Site
Halifax, Nova Scotia, Canada
Sage Investigational Site
North York, Ontario, Canada
Sage Investigational Site
Montreal, Quebec, Canada
Sage Investigational Site
Tooting, London, United Kingdom
Sage Investigational Site
Aberdeen, , United Kingdom
Sage Investigational Site
Birmingham, , United Kingdom
Sage Investigational Site
Cardiff, , United Kingdom
Sage Investigational Site
Leeds, , United Kingdom
Sage Investigational Site
Newcastle upon Tyne, , United Kingdom
Sage Investigational Site
Plymouth, , United Kingdom
Sage Investigational Site
Southampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-005577-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
718-CIH-201
Identifier Type: -
Identifier Source: org_study_id
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