Adults 25 to 65, any sex, with Huntington Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Difference in Huntington's Disease Cognitive Assessment Battery (HD-CAB) Composite Score Between Participants With HD vs HP at BaselinePrimary· Baseline
HD-CAB assesses cognitive function using 6 subtests:Symbol Digit Modalities Test-correctly coded items(0-110); One Touch Stockings of Cambridge(OTS)-mean time to reach correct response(range not defined); Trail Making Test Trail B (TMT-B)-time to complete task(0-240 sec); Hopkins Verbal Learning Test Revised-total correct recall trials(0-48); Paced Tapping Test-reciprocal of standard deviation(SD) of intertap intervals (range not defined); Emotion Recognition Test-negative emotions correctly identified(0-24). Values of OTS \& TMT B are multiplied by -1 to represent higher is better direction a
Group
Value
95% CI
Participants With HD
-3.3657
± 1.4613
Healthy Participants
0.0000
± 0.5673
Number of Participants With HD With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEsSecondary· Up to Day 42
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Treatment-emergent adverse events are defined as any adverse events with onset on or after the first dose of IP. A serious TEAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death (a life-threatening event), requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or in
TEAEs
Group
Value
95% CI
Placebo
6
SAGE-718
11
Serious TEAEs
Group
Value
95% CI
Placebo
0
SAGE-718
0
Number of Participants With HD With Clinically Significant Change From Baseline in Vital Sign MeasurementsSecondary· Up to Day 42
Vital signs including oral temperature, respiratory rate, heart rate (supine and standing), and blood pressures (supine and standing). Number of participants with clinically significant change in vital signs measurements which were deemed clinically significant by the investigator were reported.
Group
Value
95% CI
Placebo
0
SAGE-718
0
Number of Participants With HD With Clinically Significant Change From Baseline in Clinical Laboratory AssessmentsSecondary· Up to Day 42
Clinical laboratory assessments including hematology, serum chemistry, coagulation, and urinalysis were performed. Number of participants with clinically significant change in laboratory assessments which were deemed clinically significant by the investigator were reported.
Group
Value
95% CI
Placebo
0
SAGE-718
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Day 42.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary purpose of this study is to assess the magnitude of the baseline difference between participants with early Huntington's Disease (HD) and healthy participants (HP) with respect to measures of cognitive performance.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05655520 — A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease
· Phase 3
· terminated
NCT05619692 — A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzhe
· Phase 2
· completed
NCT05318937 — A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment
· Phase 2
· completed
NCT05107128 — A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)
· Phase 2
· completed
NCT04602624 — A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Demen
· Phase 2
· completed
Other recruiting trials for Huntington Disease
Currently open trials in the same condition.
NCT07326709 — A Study to Investigate the Efficacy, Safety and Tolerability of Votoplam in Participants With Huntington's Disease
· Phase 3
· recruiting
NCT07253038 — Evaluation of Three Tests to Assess Social Cognition in Huntington Disease
· recruiting
NCT06774443 — Hinting Task for Huntington's Disease
· recruiting
NCT06546488 — Cognitive Assessment Tools for Huntington's Disease.
· recruiting
NCT07010705 — Digital Measures for Clinical Trial Endpoints in Huntington's Disease
· recruiting
Other Supernus Pharmaceuticals, Inc. trials
Trials by the same sponsor.
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· recruiting
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NCT06259331 — Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Supernus Pharmaceuticals, Inc.
Last refreshed: 15 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05358821.