Phase 2 Huntington's Disease Trial, Completed NCT05107128 Sponsor: Supernus Pharmaceuticals, Inc. Condition: Huntington's Disease
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT05107128) looked at a drug called SAGE-718 in people with Huntington's disease. A total of 189 people took part — 94 received a placebo (a dummy treatment with no active ingredient) and 95 received SAGE-718. The trial's main focus was on whether SAGE-718 had any effect on a test called the Symbol Digit Modalities Test (SDMT), which measures thinking speed and attention by asking people to match symbols to numbers within 90 seconds. The trial also measured several other things, including daily independence, motor timing, problem-solving, and how much difficulty people experienced with everyday tasks at home. The reported data shows that on the primary SDMT test, both groups showed a small increase in score from where they started: the placebo group's average score went up by 2.0 points, while the SAGE-718 group's average score went up by 0.8 points (out of a possible 110). For the secondary measures, the reported data shows that on the independence scale, both groups showed a small decline (placebo: −0.8 points; SAGE-718: −1.5 points). On a timed task-switching test (Trail Making Test Part B), both groups were faster than at the start, with the placebo group taking 5.7 seconds less and the SAGE-718 group taking 10.7 seconds less. On a computerised problem-solving test, both groups showed a small improvement in response time (placebo: −4.56 seconds; SAGE-718: −3.85 seconds). On a finger-tapping timing test, the placebo group showed a small improvement (0.710 units) while the SAGE-718 group showed a small decline (−0.157 units). On a self-reported scale of difficulty with everyday tasks at home, the placebo group reported a larger improvement (−4.6 points) compared with the SAGE-718 group (−0.7 points). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Huntington's Disease Trial, Completed

NCT05107128
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been genetically confirmed to have Huntington's disease, with a specific gene change (CAG repeat of 36 or more) detected by testing.
  • Your Huntington's disease is at a mild-to-moderate stage, based on a standard rating scale score (confirm with trial site).
  • You do not have the rare childhood-onset form of Huntington's disease.
  • You show some level of cognitive (thinking and memory) difficulties, based on a standard memory and thinking test score between 15 and 25.
  • You are willing to invite a trusted person aged 18 or over (such as a family member or carer) to take part in the study alongside you, if one is available.
  • You are able to walk (using a walking aid like a cane or walker is fine, and occasional wheelchair use is acceptable), and you are able to travel to the study centre regularly throughout the trial.
  • You are able to complete a specific thinking and coordination test within 4 minutes at your screening appointment.

Who may not be able to join:

  • You have previously taken part in a study of the drug SAGE-718, have ever received gene therapy, have been in a Huntington's disease drug or device trial in the last 6 months, or have been in any other drug or device trial in the last 30 days or longer (note: if you were confirmed to have received a placebo/dummy treatment in a previous trial, you may still be eligible — confirm with trial site).
  • You have been diagnosed with another ongoing brain or neurological condition in addition to Huntington's disease, such as Alzheimer's disease, Parkinson's disease, or another form of dementia.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

Sage Investigational Site, Westmead, New South Wales
Sage Investigational Site, Herston, Queensland
Sage Investigational Site, Bethlehem, Victoria
Sage Investigational Site, Nedlands, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Supernus Pharmaceuticals, Inc.
Registry
ClinicalTrials.gov
Start date
26 January 2022
Est. completion
4 September 2024

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇬🇧 United Kingdom 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change From Baseline in the SDMT

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov