Trial · NCT05107128

A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)

NCT05107128, Phase 2, Completed, Supernus Pharmaceuticals, Inc.; results first posted 2025-09-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD). Trials, record NCT05107128. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05107128

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)
NCT number: NCT05107128
Status: Completed
Phases: Phase 2
Enrollment: 189 participants, actual
Lead sponsor: Supernus Pharmaceuticals, Inc.
Conditions: Huntington's Disease
Interventions: SAGE-718, Placebo
First posted: 2021-11-04
Last updated: 2025-09-15
Other registries' IDs: eudract:2021-005577-16
Results first posted: 2025-09-05

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in the SDMT	Baseline, Day 84	The SDMT evaluates the tracking of cognitive function over time and for the early detection of cognitive impairment. The test assesses sustained attention, processing speed, visual scanning, and psychomotor speed, with the total score reflecting the number of correct pairings (out of 110 possible) completed within 90 seconds. Scores range from 0 to 110, with higher scores indicating better cognitive performance.
Secondary	Change From Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) - Independence Scale	Baseline, Day 84	The UHDRS is a multi-domain clinical rating scale for assessment of functional capacity in HD. Independence Scale, Part V of the UHDRS, is a single-item measure to assess a participant's ability to function independently in daily activities across all stages of HD. Total score ranges from 10 to 100, with higher scores indicating better functioning. Negative change from baseline indicates worsening in functional ability.
Secondary	Change From Baseline in the Trail Making Test Part B	Baseline, Day 84	The Trail Making test is a speeded graphomotor test of visual attention and task switching. Part B includes a set-switching component that requires participants to connect a series of alternating numbers and letters in order from lowest to highest (i.e., 1-A-2-B-3-C) in the shortest time possible. The time limit to complete the task is 240 seconds, at which point the test is stopped and scored using the maximum allowable time if not yet completed. Greater time indicates greater impairment. Negative change from baseline indicates less impairment.
Secondary	Change From Baseline in the One Touch Stockings of Cambridge (OTS-Mean Latency Until Correct Response)	Baseline, Day 84	The OTS is a computerized test of executive function to assess problem-solving and planning ability. In this task, participants are shown a set of colored balls and must determine the minimum number of moves required to match a target arrangement by moving one ball at a time into one of two available locations. The goal is to perform the task using the smallest number of moves possible. The participant selects the correct number of moves from the options shown on the screen. The time to correct response is measured. Longer times indicate greater impairment. Negative change from baseline indicates an improvement in performance.
Secondary	Change From Baseline in the Paced Tapping Test (PTAP)	Baseline, Day 84	The PTAP is a test of motor timing in which participants synchronize their finger taps with auditory pacing tones during an initial paced phase. This is followed by a self-paced phase, where the tones are removed, and the participant continues tapping until a final auditory cue signals the end of the test. The primary outcome is paced tapping consistency, calculated as the inverse of the standard deviation of the intertap intervals per millisecond (1/msec), with no range specified. Higher values indicate greater timing accuracy.
Secondary	Change From Baseline in the Huntington's Disease Everyday Functioning (Hi-DEF) Home Subdomain Score	Baseline, Day 84	Hi-DEF Scale: self-reported measure to capture difficulties experienced in daily life due to HD across 4 areas of functioning: At home, At work, Driving, \& Relationships. Full scale comprises 40 items which ask participants to rate their functioning difficulty using 5-point Likert scale from 1 (No Difficulty) to 5 (Cannot do this anymore) on first 3 domains (home, work \& driving), \& 4-point scale from 1 (Never) to 4 (Always)for Relationships. Hi-DEF total score ranges from 0-154, higher score=greater difficulty. For Home subdomain, before scores can be calculated, data from item responses should be rescored so as: lowest item-level score=0 \& highest item-level score= 4. Hence, Home subdomain has 15 items scored on 5-point Likert scale, 0 indicating no difficulty \& 4 indicating cannot be done anymore, where total raw score of 0-60 are transformed to 0-100. Higher score=greater difficulty. Negative change from baseline=improvement in daily functioning.
Secondary	Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Cognitive Status Subdomain Score	Baseline, Day 84	The CGI-S scale is a validated instrument developed by the National Institute of Mental Health specifically for use in clinical studies. Cognitive Status Subdomain is one of clinical global impression severity scales domains, for which clinicians generate ratings of the severity of the participant's condition over the past 7 days (including the day of the clinic visit). The responses are scored on a scale ranging from 0 (normal - no symptoms present) to 6 (severely disabled; helpless; complete assistance needed). Higher scores indicate greater disease symptom severity. Negative change from baseline indicates an improvement in the participant's condition.
Secondary	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	Up to last follow-up visit (up to Day 112)	An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE with onset after the start of the IP, or any worsening of a pre-existing medical condition/AE with onset after the start of the IP and throughout the study.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the SDMT	Baseline, Day 84	The FAS included all participants who initiated IP and had baseline and at least 1 post-baseline efficacy evaluation. The overall number of participants analyzed indicates the number of participants with data available for this analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) - Independence Scale	Baseline, Day 84	The FAS included all participants who initiated IP and had baseline and at least 1 post-baseline efficacy evaluation. The overall number of participants analyzed indicates the number of participants with data available for this analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Trail Making Test Part B	Baseline, Day 84	Participants in the FAS who completed the Trail Making Test Part B at baseline within the allowable time limit (240 seconds) were included in this analysis. Participants who exceeded the 240-second limit at baseline were excluded. The overall number of participants analyzed reflects those with baseline results within the allowable time limit and at least one post-baseline measurement.	seconds	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the One Touch Stockings of Cambridge (OTS-Mean Latency Until Correct Response)	Baseline, Day 84	The FAS included all participants who initiated IP and had baseline and at least 1 post-baseline efficacy evaluation. The overall number of participants analyzed indicates the number of participants with data available for this analysis.	seconds	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Paced Tapping Test (PTAP)	Baseline, Day 84	The FAS included all participants who initiated IP and had baseline and at least 1 post-baseline efficacy evaluation. The overall number of participants analyzed indicates the number of participants with data available for this analysis.	1/msec	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Huntington's Disease Everyday Functioning (Hi-DEF) Home Subdomain Score	Baseline, Day 84	The FAS included all participants who initiated IP and had baseline and at least 1 post-baseline efficacy evaluation. The overall number of participants analyzed indicates the number of participants with data available for this analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Cognitive Status Subdomain Score	Baseline, Day 84	The FAS included all participants who initiated IP and had baseline and at least 1 post-baseline efficacy evaluation. The overall number of participants analyzed indicates the number of participants with data available for this analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	Up to last follow-up visit (up to Day 112)	The safety analysis set included all participants who were administered IP.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in the SDMT	Placebo	2.0	Standard Error 0.58	score on a scale
Change From Baseline in the SDMT	SAGE-718	0.8	Standard Error 0.57	score on a scale
Change From Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) - Independence Scale	Placebo	-0.8	Standard Error 0.64	score on a scale
Change From Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) - Independence Scale	SAGE-718	-1.5	Standard Error 0.63	score on a scale
Change From Baseline in the Trail Making Test Part B	Placebo	-5.7	Standard Error 4.41	seconds
Change From Baseline in the Trail Making Test Part B	SAGE-718	-10.7	Standard Error 4.11	seconds
Change From Baseline in the One Touch Stockings of Cambridge (OTS-Mean Latency Until Correct Response)	Placebo	-4.56	Standard Error 0.90	seconds
Change From Baseline in the One Touch Stockings of Cambridge (OTS-Mean Latency Until Correct Response)	SAGE-718	-3.85	Standard Error 0.88	seconds
Change From Baseline in the Paced Tapping Test (PTAP)	Placebo	0.710	Standard Error 0.4552	1/msec
Change From Baseline in the Paced Tapping Test (PTAP)	SAGE-718	-0.157	Standard Error 0.4510	1/msec

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	94
Overall Study	STARTED	SAGE-718	95
Overall Study	COMPLETED	Placebo	87
Overall Study	COMPLETED	SAGE-718	91
Overall Study	NOT COMPLETED	Placebo	7
Overall Study	NOT COMPLETED	SAGE-718	4

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Fall	Injury, poisoning and procedural complications	Placebo	10	94
other	Fall	Injury, poisoning and procedural complications	SAGE-718	11	95
other	Nausea	Gastrointestinal disorders	Placebo	10	94
other	Nausea	Gastrointestinal disorders	SAGE-718	2	95
other	Irritability	Psychiatric disorders	Placebo	7	94
other	Irritability	Psychiatric disorders	SAGE-718	2	95
other	Nasopharyngitis	Infections and infestations	Placebo	6	94
other	Nasopharyngitis	Infections and infestations	SAGE-718	2	95
other	Suicidal ideation	Psychiatric disorders	Placebo	5	94
other	Suicidal ideation	Psychiatric disorders	SAGE-718	1	95

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	94
Total, all-cause mortality	SAGE-718	0	95
Total, other adverse events	Placebo	29	94
Total, other adverse events	SAGE-718	18	95
Total, serious adverse events	Placebo	6	94
Total, serious adverse events	SAGE-718	3	95

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
SAGE-718 vs Placebo: deaths from any cause	Trial comparisons
SAGE-718 vs Placebo: serious adverse events	Trial comparisons

Tests4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
One-Touch Tower Planning	Secondary outcome	ConductCognition
Task Switching Test	Secondary outcome	ConductCognition
Tower Planning	Secondary outcome	ConductCognition
Trail Making Test B	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05107128

GET https://conductscience.org/api/trials/v1/NCT05107128/events?page=2

API reference For AI assistants