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Huntington's drug safety study halted early

NCT ID NCT05655520

Disease control Sponsor: Supernus Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if the drug SAGE-718 is safe for people with Huntington's disease when taken over a long period. It was an open-label study, meaning everyone knew they were getting the drug. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

153 people

The number who actually took part.

Started

Dec 2022

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: For all participants: * Completed 718-CIH-201 (NCT05107128) or 718-CIH-202 (NCT05358821) studies or meet eligibility criteria for the de novo cohort. * Agree to refrain from drugs of abuse for the duration of the study and from alcohol during the 48 hours preceding each study visit. * 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. * Be 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. Additional inclusion criteria for the de novo cohort (Cohort 3): * Be at least 25 years old, but not older than 65 years of age at Screening. * Genetically confirmed disease with cytosine-adenine-guanine (CAG) expansion ≥40 * No features of juvenile HD * CAG-Age-Product (CAP) score ≥90, as calculated using the CAP formula: AGE × (CAG - 30) / 6.49. * At screening, scores of either: a) Unified Huntington's Disease Rating Scale (UHDRS) -Total Functional Capacity (TFC)=13 and Montreal Cognitive Assessment (MoCA) ≤25 score, or b) UHDRS-TFC ≤12 and MoCA \>25 Exclusion Criteria: For all participants * 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. * Had gastric bypass surgery, has a gastric sleeve or lap band, or has had any related procedures that interfere with gastrointestinal transit. * Is known to be allergic to any of SAGE-718 excipients, including soy lecithin. * Receive any prohibited medications within 30 days of screening and during participation in the study. Additional exclusion criteria for the de novo cohort (Cohort 3): * Have previous exposure to gene therapy, or have participated in any other 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). Additionally, participants who have received treatment with antisense oligonucleotides or a messenger ribonucleic acid (mRNA) splicing modifier will be excluded. Note: Participants with confirmation of enrolment in the placebo arm of these investigational trials would not be excluded. Additional exclusion criteria for 718-CIH-201/202 completers (Cohorts 1 and 2): * Have one or more ongoing serious adverse events (SAEs) from the parent study. * Have ongoing, unresolved AE(s), which in the opinion of the investigator or sponsor, is likely to interfere with study conduct or compliance.

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Conditions

The condition(s) this trial relates to.

Huntington disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Huntington's disease

Contacts and locations

Locations

  • Sage Investigational Site

    Birmingham, Alabama, 35233, United States

  • Sage Investigational Site

    Little Rock, Arkansas, 72205, United States

  • Sage Investigational Site

    La Jolla, California, 92037, United States

  • Sage Investigational Site

    Los Alamitos, California, 90720, United States

  • Sage Investigational Site

    Los Angeles, California, 90095, United States

  • Sage Investigational Site

    Sacramento, California, 95817, United States

  • Sage Investigational Site

    Englewood, Colorado, 80113, United States

  • Sage Investigational Site

    Washington D.C., District of Columbia, 20007, United States

  • Sage Investigational Site

    Boca Raton, Florida, 33431, United States

  • Sage Investigational Site

    Tampa, Florida, 33612, United States

  • Sage Investigational Site

    Chicago, Illinois, 60611, United States

  • Sage Investigational Site

    Chicago, Illinois, 60612, United States

  • Sage Investigational Site

    Indianapolis, Indiana, 46202, United States

  • Sage Investigational Site

    Iowa City, Iowa, 52242, United States

  • Sage Investigational Site

    Kansas City, Kansas, 66103, United States

  • Sage Investigational Site

    Baltimore, Maryland, 21287, United States

  • Sage Investigational Site

    Boston, Massachusetts, 02215, United States

  • Sage Investigational Site

    New York, New York, 10032, United States

  • Sage Investigational Site

    Williamsville, New York, 14221, United States

  • Sage Investigational Site

    Chapel Hill, North Carolina, 27599, United States

  • Sage Investigational Site

    Durham, North Carolina, 27705, United States

  • Sage Investigational Site

    Cincinnati, Ohio, 45219, United States

  • Sage Investigational Site

    Toledo, Ohio, 43614, United States

  • Sage Investigational Site

    Philadelphia, Pennsylvania, 19107, United States

  • Sage Investigational Site

    Charleston, South Carolina, 29425, United States

  • Sage Investigational Site

    Memphis, Tennessee, 38157, United States

  • Sage Investigational Site

    Houston, Texas, 77030, United States

  • Sage Investigational Site

    Richmond, Virginia, 23298, United States

  • Sage Investigational Site

    Spokane, Washington, 99202, United States

  • Sage Investigational Site

    Westmead, New South Wales, 2145, Australia

  • Sage Investigational Site

    Caulfield South, Victoria, 3162, Australia

  • Sage Investigational Site

    Nedlands, Western Australia, 6009, Australia

  • Sage Investigational Site

    Halifax, Nova Scotia, B3S1N2, Canada

  • Sage Investigational Site

    Toronto, Ontario, M2K 1E1, Canada

  • Sage Investigational Site

    Montreal, Quebec, H2X1R9, Canada

  • Sage Investigational Site

    Plymouth, Derriford, PL6 8BT, United Kingdom

  • Sage Investigational Site

    Southampton, England, SO16 6YD, United Kingdom

  • Sage Investigational Site

    Tooting, London, SW17 0QT, United Kingdom

  • Sage Investigational Site

    Aberdeen, Scotland, AB25 2ZA, United Kingdom

  • Sage Investigational Site

    Newcastle, Upon Tyne, NE6 4QD, United Kingdom

  • Sage Investigational Site

    Cardiff, Wales, CF144XW, United Kingdom

  • Sage Investigational Site

    Birmingham, West Midlands, B15 2FG, United Kingdom

  • Sage Investigational Site

    Leeds, West Yorkshire, LS7 4SA, United Kingdom

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