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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05107128




Registration number
NCT05107128
Ethics application status
Date submitted
25/10/2021
Date registered
4/11/2021
Date last updated
16/01/2024

Titles & IDs
Public title
A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)
Scientific title
A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease
Secondary ID [1] 0 0
2021-005577-16
Secondary ID [2] 0 0
718-CIH-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SAGE-718
Treatment: Drugs - Placebo

Experimental: SAGE-718 - Participants will receive SAGE-718, once daily for 84 days.

Placebo Comparator: Placebo - Participants will receive placebo, once daily for 84 days.


Treatment: Drugs: SAGE-718
Oral capsules.

Treatment: Drugs: Placebo
SAGE-718-matching oral capsules.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the Huntington's Disease Cognitive Assessment Battery (HD-CAB) Composite Score
Timepoint [1] 0 0
Baseline and Day 84
Secondary outcome [1] 0 0
Change From Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) - Independence Scale
Timepoint [1] 0 0
Baseline and Day 84
Secondary outcome [2] 0 0
Change From Baseline in the UHDRS - Total Motor Score (TMS)
Timepoint [2] 0 0
Baseline and Day 84
Secondary outcome [3] 0 0
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [3] 0 0
Up to approximately 112 days

Eligibility
Key inclusion criteria
1. Meet all the following criteria for HD at Screening (Days -28 to -2):

1. Genetically confirmed disease with huntingtin gene CAG expansion =36.

2. At screening, UHDRS-Total Functional Capacity (TFC) score >6 and <13 suggesting
no more than a moderate level of functional impairment.

3. No features of juvenile HD.

2. Score of 15 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at screening
indicating the presence of cognitive impairment.

3. 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.

4. 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.
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.)

2. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
178
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Sage Investigational Site - Westmead
Recruitment hospital [2] 0 0
Sage Investigational Site - Herston
Recruitment hospital [3] 0 0
Sage Investigational Site - Parkdale
Recruitment hospital [4] 0 0
Sage Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3195 - Parkdale
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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California
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United States of America
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Colorado
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District of Columbia
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United States of America
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Florida
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United States of America
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Hawaii
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Kansas
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Maryland
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Massachusetts
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New York
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North Carolina
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United States of America
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Canada
State/province [22] 0 0
Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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United Kingdom
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London
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United Kingdom
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Aberdeen
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United Kingdom
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Birmingham
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United Kingdom
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Cardiff
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United Kingdom
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Leeds
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Plymouth
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United Kingdom
State/province [32] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sage Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive
performance and functioning in participants with HD.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05107128
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Grant Rutledge, PhD
Address 0 0
Country 0 0
Phone 0 0
339-368-8432
Fax 0 0
Email 0 0
grant.rutledge@sagerx.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05107128