Trial · NCT05655520
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease
NCT05655520, Phase 3, Terminated, Supernus Pharmaceuticals, Inc.; results first posted 2025-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease. Trials, record NCT05655520. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05655520
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease
- NCT number
- NCT05655520
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 153 participants, actual
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Conditions
- Huntington's Disease
- Interventions
- SAGE-718
- First posted
- 2022-12-19
- Last updated
- 2025-12-17
- Results first posted
- 2025-12-17
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) | Up to 24 months | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. |
| Primary | Number of Participants With at Least One TEAE by Severity | Up to 24 months | A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Severity was assessed as: Mild: symptoms barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptoms. Moderate: symptoms of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptoms may be needed. Severe: symptoms cause severe discomfort; symptoms cause incapacitation or significant impact on participant's daily life; severity may cause cessation of treatment with IP; treatment for symptoms may be given and/or participant hospitalized. Participant with multiple instances of events is counted only once using maximum intensity. |
| Primary | Number of Participants Who Withdrew From Study Due to TEAEs | Up to 24 months | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE with onset or after the start of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. |
| Primary | Change From Baseline in Vital Signs: Blood Pressure | Baseline; Last Value on Study (up to 24 months) | Vital signs parameter for blood pressure included systolic blood pressure (supine), systolic blood pressure (standing 1 minute), systolic blood pressure (standing 3 minutes), diastolic blood pressure (supine), diastolic blood pressure (standing 1 minute), and diastolic blood pressure (standing 3 minutes). Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Primary | Change From Baseline in Vital Signs: Heart Rate | Baseline, Last value on study (up to 24 months) | Vital signs for heart rate included heart rate (supine), heart rate (standing 1 minute), and heart rate (standing 3 minute). Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Primary | Change From Baseline in Vital Signs: Respiratory Rate | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Primary | Change From Baseline in Vital Signs: Temperature | Baseline, Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Primary | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Primary | Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | Baseline, Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Primary | Change From Baseline in Clinical Laboratory Parameters: Hematology- Erythrocytes (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin | Baseline, Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) | Up to 24 months | The Safety Set included all participants who were administered IP during the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With at Least One TEAE by Severity | Up to 24 months | The Safety Set included all participants who were administered IP during the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Withdrew From Study Due to TEAEs | Up to 24 months | The Safety Set included all participants who were administered IP during the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Vital Signs: Blood Pressure | Baseline; Last Value on Study (up to 24 months) | The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for vital sign parameters for this outcome measure. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Vital Signs: Heart Rate | Baseline, Last value on study (up to 24 months) | The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for vital sign parameters for this outcome measure. | beats/min | MEAN |
| PRIMARY | Change From Baseline in Vital Signs: Respiratory Rate | Baseline; Last value on study (up to 24 months) | The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for vital sign parameters for this outcome measure. | breaths/min | MEAN |
| PRIMARY | Change From Baseline in Vital Signs: Temperature | Baseline, Last value on study (up to 24 months) | The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for vital sign parameters for this outcome measure. | degree Celsius | MEAN |
| PRIMARY | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | Baseline; Last value on study (up to 24 months) | The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure and Number analyzed is the number of participants with data available for analysis. | cells*10^9/L | MEAN |
| PRIMARY | Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | Baseline, Last value on study (up to 24 months) | The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure. | percent | MEAN |
| PRIMARY | Change From Baseline in Clinical Laboratory Parameters: Hematology- Erythrocytes (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin | Baseline, Last value on study (up to 24 months) | The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure. | grams per liter (g/L) | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group260
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) | Cohort 1 (Direct Rollover) | 46 | Participants | ||
| Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) | Cohort 2 (Gap Rollover) | 46 | Participants | ||
| Number of Participants With at Least One TEAE by Severity | Cohort 1 (Direct Rollover) | Mild | 21 | Participants | |
| Number of Participants With at Least One TEAE by Severity | Cohort 2 (Gap Rollover) | Mild | 24 | Participants | |
| Number of Participants With at Least One TEAE by Severity | Cohort 1 (Direct Rollover) | Moderate | 22 | Participants | |
| Number of Participants With at Least One TEAE by Severity | Cohort 2 (Gap Rollover) | Moderate | 18 | Participants | |
| Number of Participants With at Least One TEAE by Severity | Cohort 1 (Direct Rollover) | Severe | 3 | Participants | |
| Number of Participants With at Least One TEAE by Severity | Cohort 2 (Gap Rollover) | Severe | 4 | Participants | |
| Number of Participants Who Withdrew From Study Due to TEAEs | Cohort 1 (Direct Rollover) | 2 | Participants | ||
| Number of Participants Who Withdrew From Study Due to TEAEs | Cohort 2 (Gap Rollover) | 3 | Participants |
1 to 10 of 260Source ClinicalTrials.gov
See all 260 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (Direct Rollover) | 72 | |
| Overall Study | STARTED | Cohort 2 (Gap Rollover) | 81 | |
| Overall Study | COMPLETED | Cohort 1 (Direct Rollover) | 2 | |
| Overall Study | COMPLETED | Cohort 2 (Gap Rollover) | 4 | |
| Overall Study | NOT COMPLETED | Cohort 1 (Direct Rollover) | 70 | |
| Overall Study | NOT COMPLETED | Cohort 2 (Gap Rollover) | 77 |
Source ClinicalTrials.gov
Adverse events54
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 | Events |
|---|---|---|---|---|---|---|
| other | Fall | Injury, poisoning and procedural complications | Cohort 1 (Direct Rollover) | 6 | 72 | |
| other | Fall | Injury, poisoning and procedural complications | Cohort 2 (Gap Rollover) | 9 | 81 | |
| other | Nasopharyngitis | Infections and infestations | Cohort 1 (Direct Rollover) | 6 | 72 | |
| other | Nasopharyngitis | Infections and infestations | Cohort 2 (Gap Rollover) | 4 | 81 | |
| other | Depression | Psychiatric disorders | Cohort 1 (Direct Rollover) | 5 | 72 | |
| other | Depression | Psychiatric disorders | Cohort 2 (Gap Rollover) | 4 | 81 | |
| other | Anxiety | Psychiatric disorders | Cohort 1 (Direct Rollover) | 5 | 72 | |
| other | Anxiety | Psychiatric disorders | Cohort 2 (Gap Rollover) | 2 | 81 | |
| other | Balance disorder | Nervous system disorders | Cohort 1 (Direct Rollover) | 4 | 72 | |
| other | Balance disorder | Nervous system disorders | Cohort 2 (Gap Rollover) | 3 | 81 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (Direct Rollover) | 0 | 72 |
| Total, all-cause mortality | Cohort 2 (Gap Rollover) | 0 | 81 |
| Total, other adverse events | Cohort 1 (Direct Rollover) | 46 | 72 |
| Total, other adverse events | Cohort 2 (Gap Rollover) | 22 | 81 |
| Total, serious adverse events | Cohort 1 (Direct Rollover) | 3 | 72 |
| Total, serious adverse events | Cohort 2 (Gap Rollover) | 6 | 81 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 (Direct Rollover) vs Cohort 2 (Gap Rollover): Number of Participants Who Withdrew From Study Due to TEAEs | Trial comparisons |
| Cohort 1 (Direct Rollover) vs Cohort 2 (Gap Rollover): deaths from any cause | Trial comparisons |
| Cohort 1 (Direct Rollover) vs Cohort 2 (Gap Rollover): Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) | Trial comparisons |
| Cohort 1 (Direct Rollover) vs Cohort 2 (Gap Rollover): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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/NCT05655520
GET https://conductscience.org/api/trials/v1/NCT05655520/registered?page=2