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New drug aims to sharpen thinking in Huntington's patients

NCT ID NCT05358821

Symptom relief 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether SAGE-718, an experimental oral drug, can improve cognitive function in people with early Huntington's disease. 69 participants took either the drug or a placebo for 28 days. The main goal was to measure changes in thinking skills using a battery of cognitive tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAGE-718 (oral capsules)
What this could lead to
If successful, this could point toward a treatment to improve thinking and daily functioning in people with early Huntington's disease.
What could go wrong
This is a small, early-phase trial (Phase 2) with only 69 participants. The drug may not show meaningful benefits over placebo, and side effects are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

69 people

The number who actually took part.

Started

May 2022

Finished

Apr 2024

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

Accepted

You do not need to have the condition being studied to take part.

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 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: For All 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.

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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 disease

Contacts and locations

Locations

  • Sage Investigational Site

    Birmingham, Alabama, 35233, United States

  • Sage Investigational Site

    Los Alamitos, California, 90720, United States

  • Sage Investigational Site

    Englewood, Colorado, 80113, United States

  • Sage Investigational Site

    Washington D.C., District of Columbia, 20057, United States

  • Sage Investigational Site

    Boca Raton, Florida, 33431, United States

  • Sage Investigational Site

    Tampa, Florida, 33602, United States

  • Sage Investigational Site

    Chicago, Illinois, 60612, United States

  • Sage Investigational Site

    Baltimore, Maryland, 21218, United States

  • Sage Investigational Site

    New York, New York, 10027, United States

  • Sage Investigational Site

    Chapel Hill, North Carolina, 27599, United States

  • Sage Investigational Site

    Cincinnati, Ohio, 45221, United States

  • Sage Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • Sage Investigational Site

    Houston, Texas, 77030, United States

  • Sage Investigational Site

    Montreal, H2X 3E4, Canada

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