Trial · NCT05358821

28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease

NCT05358821, Phase 2, Completed, Supernus Pharmaceuticals, Inc.; results first posted 2025-05-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease. Trials, record NCT05358821. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05358821

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Trial

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

Title: 28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease
NCT number: NCT05358821
Status: Completed
Phases: Phase 2
Enrollment: 69 participants, actual
Lead sponsor: Supernus Pharmaceuticals, Inc.
Conditions: Huntington Disease
Interventions: SAGE-718, Placebo
First posted: 2022-05-03
Last updated: 2025-09-15
Results first posted: 2025-05-06

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Difference in Huntington's Disease Cognitive Assessment Battery (HD-CAB) Composite Score Between Participants With HD vs HP at Baseline	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 as other tests. Each of 6 subtests scores was transformed to z-score(range not defined;low negative value represents cognitive impairment), which is calculated by subtracting mean and dividing by SD of HP at baseline. HD-CAB composite=average of 6 z-scores. Negative HD-CAB of HD participants=decline in cognitive function relative to HP. Assessment is relative to reference group(healthy population).
Secondary	Number of Participants With HD With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	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 incapacity, results in a congenital abnormality or birth defect.
Secondary	Number of Participants With HD With Clinically Significant Change From Baseline in Vital Sign Measurements	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.
Secondary	Number of Participants With HD With Clinically Significant Change From Baseline in Clinical Laboratory Assessments	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.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Difference in Huntington's Disease Cognitive Assessment Battery (HD-CAB) Composite Score Between Participants With HD vs HP at Baseline	Baseline	FAS included all randomized participants with HD \& all HP who met eligibility criteria \& had at least 1 baseline assessment of HD-CAB (participants with HD \& HP). As primary analysis was to estimate baseline differences between participants with HD \& HP in HD-CAB composite score, data from SAGE-718 \& placebo arms were combined for analysis. Baseline for HD participants=last non-missing measurement prior to first dose of IP. Baseline for HP=last non-missing measurement on or prior to Day 1.	Z score	MEAN
SECONDARY	Number of Participants With HD With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	Up to Day 42	Safety Set included all participants with HD who were administered IP or HP who met eligibility criteria and was used to describe the safety data.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With HD With Clinically Significant Change From Baseline in Vital Sign Measurements	Up to Day 42	Safety Set included all participants with HD who were administered IP or HP who met eligibility criteria and was used to describe the safety data.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With HD With Clinically Significant Change From Baseline in Clinical Laboratory Assessments	Up to Day 42	Safety Set included all participants with HD who were administered IP or HP who met eligibility criteria and was used to describe the safety data.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Category	Value	Spread	Units
Difference in Huntington's Disease Cognitive Assessment Battery (HD-CAB) Composite Score Between Participants With HD vs HP at Baseline	Participants With HD		-3.3657	Standard Deviation 1.4613	Z score
Difference in Huntington's Disease Cognitive Assessment Battery (HD-CAB) Composite Score Between Participants With HD vs HP at Baseline	Healthy Participants		0.0000	Standard Deviation 0.5673	Z score
Number of Participants With HD With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	Placebo	TEAEs	6		Participants
Number of Participants With HD With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	SAGE-718	TEAEs	11		Participants
Number of Participants With HD With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	Placebo	Serious TEAEs	0		Participants
Number of Participants With HD With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	SAGE-718	Serious TEAEs	0		Participants
Number of Participants With HD With Clinically Significant Change From Baseline in Vital Sign Measurements	Placebo		0		Participants
Number of Participants With HD With Clinically Significant Change From Baseline in Vital Sign Measurements	SAGE-718		0		Participants
Number of Participants With HD With Clinically Significant Change From Baseline in Clinical Laboratory Assessments	Placebo		0		Participants
Number of Participants With HD With Clinically Significant Change From Baseline in Clinical Laboratory Assessments	SAGE-718		0		Participants

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	19
Overall Study	STARTED	SAGE-718	21
Overall Study	STARTED	Healthy Participants	29
Overall Study	COMPLETED	Placebo	19
Overall Study	COMPLETED	SAGE-718	20
Overall Study	COMPLETED	Healthy Participants	28
Overall Study	NOT COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	SAGE-718	1
Overall Study	NOT COMPLETED	Healthy Participants	1

Source ClinicalTrials.gov

Adverse events36

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	Nausea	Gastrointestinal disorders	Placebo	0	19
other	Nausea	Gastrointestinal disorders	SAGE-718	3	21
other	Nausea	Gastrointestinal disorders	Healthy Participants	1	29
other	Dyspepsia	Gastrointestinal disorders	Placebo	1	19
other	Dyspepsia	Gastrointestinal disorders	SAGE-718	0	21
other	Dyspepsia	Gastrointestinal disorders	Healthy Participants	0	29
other	Fatigue	General disorders	Placebo	0	19
other	Fatigue	General disorders	SAGE-718	2	21
other	Fatigue	General disorders	Healthy Participants	0	29
other	Nasopharyngitis	Infections and infestations	Placebo	1	19

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	19
Total, all-cause mortality	SAGE-718	0	21
Total, all-cause mortality	Healthy Participants	0	29
Total, other adverse events	Placebo	6	19
Total, other adverse events	SAGE-718	7	21
Total, other adverse events	Healthy Participants	4	29
Total, serious adverse events	Placebo	0	19
Total, serious adverse events	SAGE-718	0	21
Total, serious adverse events	Healthy Participants	0	29

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: Number of Participants With HD With Clinically Significant Change From Baseline in Vital Sign Measurements	Trial comparisons
SAGE-718 vs Placebo: Number of Participants With HD With Clinically Significant Change From Baseline in Clinical Laboratory Assessments	Trial comparisons

Tests6

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
Emoji Emotion Recognition	Primary outcome	ConductCognition
One-Touch Tower Planning	Primary outcome	ConductCognition
Symbol Coding	Primary outcome	ConductCognition
Tower Planning	Primary outcome	ConductCognition
Trail Making Test B	Primary outcome	ConductCognition
Verbal Learning	Primary 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/NCT05358821

GET https://conductscience.org/api/trials/v1/NCT05358821/events?page=2

API reference For AI assistants