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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005577-16 | EudraCT Number |
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The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance and functioning in participants with HD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive SAGE-718-matching placebo, orally, once daily (QD) for up to Day 84. |
|
| SAGE-718 | Experimental | Participants will receive SAGE-718, 1.2 milligrams (mg), capsules, orally, QD for Days 1 to 27, followed by 0.9 mg for the remainder of the treatment period up to Day 84. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAGE-718 | Drug | Oral capsules. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the SDMT | 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. | Baseline, Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) - Independence Scale | 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. |
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Inclusion Criteria:
Meet all the following criteria for HD at Screening (Days -28 to -2):
Score of 15 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at screening indicating the presence of cognitive impairment.
Be willing to invite a study partner, if available, who is reliable, competent, and at least 18 years of age to participate in the study.
Be ambulatory (use of assistance devices such as a walker or cane is acceptable, as is occasional use of wheelchair, as judged by the investigator. Individuals requiring a wheelchair on a regular basis are excluded), able to travel to the study center, and, as judged by the investigator, is likely to be able to continue to travel to the study center to complete study visits for the duration of the study.
Completion of Huntington's Disease Cognitive Assessment Battery (HD-CAB) Trail Making-B Test in less than 240 seconds at Screening (Days -28 to -2).
Exclusion Criteria:
Have participated in a previous clinical study of SAGE-718, have previous exposure to gene therapy, have participated in any HD investigational drug, biologic, or device trial within 180 days, or a non-HD drug, biologic, or device trial within 30 days or 5 half-lives (whichever is longer).
(Note: Participants with confirmation of enrollment in the placebo arm of these trials would not be excluded.)
Have a diagnosis of an ongoing neurodegenerative condition other than HD, including but not limited to Alzheimer's Disease, vascular dementia, dementia with Lewy bodies, or Parkinson's Disease.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sage Investigational Site | Little Rock | Arkansas | 72205 | United States | ||
| Sage Investigational Site |
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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A total of 309 participants with Huntington's disease (HD) were screened, of which 189 participants were randomized to receive either SAGE-718 or placebo.
Participants took part in the study at investigative sites from 26 January 2022 to 03 October 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received SAGE-718-matching placebo, orally, once daily (QD) for up to Day 84. |
| FG001 | SAGE-718 | Participants received SAGE-718, 1.2 milligrams (mg), capsules, orally, QD for Days 1 to 27, followed by 0.9 mg for the remainder of the treatment period up to Day 84. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 20, 2024 | Jul 30, 2025 |
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| Drug |
SAGE-718-matching oral capsules. |
|
| Baseline, Day 84 |
| Change From Baseline in the Trail Making Test Part B | 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. | Baseline, Day 84 |
| Change From Baseline in the One Touch Stockings of Cambridge (OTS-Mean Latency Until Correct Response) | 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. | Baseline, Day 84 |
| Change From Baseline in the Paced Tapping Test (PTAP) | 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. | Baseline, Day 84 |
| Change From Baseline in the Huntington's Disease Everyday Functioning (Hi-DEF) Home Subdomain Score | 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. | Baseline, Day 84 |
| Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Cognitive Status Subdomain Score | 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. | Baseline, Day 84 |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. | Up to last follow-up visit (up to Day 112) |
| La Jolla |
| California |
| 92037 |
| United States |
| Sage Investigational Site | Los Angeles | California | 90095 | United States |
| Sage Investigational Site | Sacramento | California | 95817 | United States |
| Sage Investigational Site | Englewood | Colorado | 80113 | United States |
| Sage Investigational Site | Washington D.C. | District of Columbia | 20007 | United States |
| Sage Investigational Site | Boca Raton | Florida | 33431 | United States |
| Sage Investigational Site | Boca Raton | Florida | 33486 | United States |
| Sage Investigational Site | Tampa | Florida | 33612 | United States |
| Sage Investigational Site | Honolulu | Hawaii | 96817 | United States |
| Sage Investigational Site | Chicago | Illinois | 60611 | United States |
| Sage Investigational Site | Chicago | Illinois | 60612 | United States |
| Sage Investigational Site | Indianapolis | Indiana | 46202 | United States |
| Sage Investigational Site | Iowa City | Iowa | 52242 | United States |
| Sage Investigational Site | Kansas City | Kansas | 66160 | United States |
| Sage Investigational Site | Baltimore | Maryland | 21287 | United States |
| Sage Investigational Site | Boston | Massachusetts | 02129 | United States |
| Sage Investigational Site | Boston | Massachusetts | 02215 | United States |
| Sage Investigational Site | Farmington Hills | Michigan | 48334 | United States |
| Sage Investigational Site | Buffalo | New York | 14221 | United States |
| Sage Investigational Site | New York | New York | 10032 | United States |
| Sage Investigational Site | Chapel Hill | North Carolina | 27599 | United States |
| Sage Investigational Site | Durham | North Carolina | 27705 | United States |
| Sage Investigational Site | Cincinnati | Ohio | 45219 | United States |
| Sage Investigational Site | Toledo | Ohio | 43614 | United States |
| Sage Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Sage Investigational Site | Charleston | South Carolina | 29425 | United States |
| Sage Investigational Site | Memphis | Tennessee | 38157 | United States |
| Sage Investigational Site | Nashville | Tennessee | 37212 | United States |
| Sage Investigational Site | Houston | Texas | 77030 | United States |
| Sage Investigational Site | Richmond | Virginia | 23298 | United States |
| Sage Investigational Site | Kirkland | Washington | 98034 | United States |
| Sage Investigational Site | Spokane | Washington | 99202 | United States |
| Sage Investigational Site | Madison | Wisconsin | 53792 | United States |
| Sage Investigational Site | Westmead | New South Wales | 2145 | Australia |
| Sage Investigational Site | Herston | Queensland | 4029 | Australia |
| Sage Investigational Site | Bethlehem | Victoria | 3162 | Australia |
| Sage Investigational Site | Nedlands | Western Australia | 6009 | Australia |
| Sage Investigational Site | Halifax | Nova Scotia | B3S 1N2 | Canada |
| Sage Investigational Site | North York | Ontario | M2K 1E1 | Canada |
| Sage Investigational Site | Montreal | Quebec | H2X 0A9 | Canada |
| Sage Investigational Site | Tooting | London | SW17 0QT | United Kingdom |
| Sage Investigational Site | Aberdeen | AB25 2ZA | United Kingdom |
| Sage Investigational Site | Birmingham | B15 2FG | United Kingdom |
| Sage Investigational Site | Cardiff | CF10 3AX | United Kingdom |
| Sage Investigational Site | Leeds | LS7 4SA | United Kingdom |
| Sage Investigational Site | Newcastle upon Tyne | NE6 4QD | United Kingdom |
| Sage Investigational Site | Plymouth | PL6 8BT | United Kingdom |
| Sage Investigational Site | Southampton | SO16 6YD | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full Analysis Set (FAS) included all participants who initiated investigational product (IP) and had baseline and at least 1 post-baseline efficacy evaluation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received SAGE-718-matching placebo, orally, QD for up to Day 84. |
| BG001 | SAGE-718 | Participants received SAGE-718, 1.2 mg, capsules, orally, QD for Days 1 to 27, followed by 0.9 mg for the remainder of the treatment period up to Day 84. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Symbol Digit Modalities Test (SDMT) Score | 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. | Mean | Standard Deviation | score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the SDMT | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Day 84 |
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| Secondary | Change From Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) - Independence Scale | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Day 84 |
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| Secondary | Change From Baseline in the Trail Making Test Part B | 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. | 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. | Posted | Least Squares Mean | Standard Error | seconds | Baseline, Day 84 |
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| Secondary | Change From Baseline in the One Touch Stockings of Cambridge (OTS-Mean Latency Until Correct Response) | 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. | 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. | Posted | Least Squares Mean | Standard Error | seconds | Baseline, Day 84 |
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| Secondary | Change From Baseline in the Paced Tapping Test (PTAP) | 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. | 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. | Posted | Least Squares Mean | Standard Error | 1/msec | Baseline, Day 84 |
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| Secondary | Change From Baseline in the Huntington's Disease Everyday Functioning (Hi-DEF) Home Subdomain Score | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Day 84 |
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| Secondary | Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Cognitive Status Subdomain Score | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Day 84 |
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| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. | The safety analysis set included all participants who were administered IP. | Posted | Number | percentage of participants | Up to last follow-up visit (up to Day 112) |
|
|
Up to last follow-up visit (up to Day 112)
The safety analysis set included all participants who were administered IP.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received SAGE-718-matching placebo, orally, QD for up to Day 84. | 0 | 94 | 6 | 94 | 29 | 94 |
| EG001 | SAGE-718 | Participants received SAGE-718, 1.2 mg, capsules, orally, QD for Days 1 to 27, followed by 0.9 mg for the remainder of the treatment period up to Day 84. | 0 | 95 | 3 | 95 | 18 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Bullock, PhD | Sage Therapeutics | 617-949-5151 | amy.bullock@sagerx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2024 | Jul 30, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Participants |
|
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Counts |
|---|
| Participants |
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Participants received SAGE-718, 1.2 mg, capsules, orally, QD for Days 1 to 27, followed by 0.9 mg for the remainder of the treatment period up to Day 84. |
|
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| Units | Counts |
|---|---|
| Participants |
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