28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease
NCT ID: NCT05358821
Last Updated: 2025-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2022-05-26
2024-04-10
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
QUADRUPLE
Study Groups
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SAGE-718
Participants with HD will receive SAGE-718 1.2 milligrams (mg), orally, once daily for up to 28 days.
SAGE-718
SAGE-718 oral softgel lipid capsules
Placebo
Participants with HD will receive SAGE-718-matching placebo, orally, once daily for up to 28 days.
Placebo
SAGE-718-matching oral capsules
Healthy Participants
HP enrolled in this study will not receive any investigational product (IP) (SAGE-718 or placebo).
No interventions assigned to this group
Interventions
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SAGE-718
SAGE-718 oral softgel lipid capsules
Placebo
SAGE-718-matching oral capsules
Eligibility Criteria
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Inclusion Criteria
1. Agree to refrain from drugs of abuse for the duration of the study and from alcohol during the 48 hours preceding each study visit.
Additional criteria for participants with HD only:
2. Be ambulatory, able to travel to the study center, and, 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.
3. Have:
1. Genetically confirmed disease with cytosine, adenine, and guanine (CAG) expansion ≥36.
2. At screening, Unified Huntington's Disease Rating Scale (UHDRS) Total Functional Capacity (TFC) \>6 and \<13, suggesting no more than a moderate level of functional impairment.
3. No features of juvenile HD.
4. CAG-Age-Product (CAP) score \>70, as calculated using the CAP formula: Age × (CAG - 30) / 6.49.
5. Score of 15 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at screening, indicating the presence of cognitive impairment.
Additional criteria for HP only:
1. Score ≥26 on the MoCA at screening.
2. Have no known family history of HD; or, have known family history of HD but have genetic test results available that show a normal CAG repeat length for both Huntingtin (HTT) alleles (\<36).
Exclusion Criteria
1. Receive any prohibited medications within 30 days of Screening and during participation in the study
2. Have participated in a previous clinical study of SAGE-718, have previous exposure to gene therapy; or 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 enrolment in the placebo arm of these trials would not be excluded.)
3. Is known to be allergic to any of SAGE-718 excipients, including soy lecithin.
Additional criteria for participants with HD only:
1. Had gastric bypass surgery, has a gastric sleeve or lap band, or has had any related procedures that interfere with gastrointestinal transit.
2. Receive any prohibited medications within 30 days of Screening and during participation in the study.
25 Years
65 Years
ALL
Yes
Sponsors
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Supernus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Sage Investigational Site
Birmingham, Alabama, United States
Sage Investigational Site
Los Alamitos, 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
Tampa, Florida, United States
Sage Investigational Site
Chicago, Illinois, United States
Sage Investigational Site
Baltimore, Maryland, United States
Sage Investigational Site
New York, New York, United States
Sage Investigational Site
Chapel Hill, North Carolina, United States
Sage Investigational Site
Cincinnati, Ohio, United States
Sage Investigational Site
Philadelphia, Pennsylvania, United States
Sage Investigational Site
Houston, Texas, United States
Sage Investigational Site
Montreal, , Canada
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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718-CIH-202
Identifier Type: -
Identifier Source: org_study_id
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