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SAGE-718 for Huntington's Disease
Phase 2
Waitlist Available
Research Sponsored by Sage Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No features of juvenile HD [ie, Unified Huntington's Disease Rating Scale(UHDRS) Diagnostic Confidence Level (DCL) = 4 before age 25].
Genetically confirmed disease with cytosine, adenine, and guanine (CAG) expansion ≥36
Timeline
Screening 3 weeks
Treatment Varies
Follow Up form first dose of study drug up to day 42
Awards & highlights
Study Summary
This trial is comparing the effects of a new drug to Huntington's patients versus a placebo, and looking at cognitive differences between the two groups.
Who is the study for?
This trial is for adults with early Huntington's Disease who have a moderate level of functional impairment and cognitive challenges, but can still get around and travel to the study center. They must not use drugs or alcohol before visits, have no juvenile HD features, and meet specific genetic criteria. Healthy participants without HD or with a normal CAG repeat length can also join.Check my eligibility
What is being tested?
The study is testing SAGE-718 against a placebo over 28 days to see if it improves cognitive performance in people with early Huntington's Disease compared to healthy individuals.See study design
What are the potential side effects?
Potential side effects are not detailed here, but as SAGE-718 is under investigation, they may include reactions related to its ingredients like soy lecithin. Participants allergic to any components should avoid this trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was not diagnosed with juvenile Huntington's Disease before age 25.
Select...
My genetic test shows a CAG repeat of 36 or more.
Select...
My Huntington's disease did not start when I was a child.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in Huntington's Disease Cognitive Assessment Battery (HD-CAB) Composite Score Between Participants With HD vs HP at Baseline
Secondary outcome measures
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Percentage of Participants With Clinically Significant Changes in Laboratory Assessments
Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements
Other outcome measures
Cambridge Neuropsychological Test Automated Battery (CANTAB) Test at Baseline
Change From Baseline in the Cambridge Neuropsychological Test Automated Battery (CANTAB) Test
Change From Baseline in the Huntington's Disease Cognitive Assessment Battery (HD-CAB) Composite Score
+2 moreSide effects data
From 2022 Phase 2 trial • 18 Patients • NCT044760179%
Activated partial thromboplastin time prolonged
9%
International normalized ratio increased
9%
Leukocyturia
9%
Skin laceration
9%
Large intestine polyp
9%
Asthenia
9%
Urinary tract infection
9%
Eye contusions
9%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: SAGE-718 3 mg
Part B: SAGE-718 3 mg
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SAGE-718Experimental Treatment1 Intervention
Participants will receive SAGE-718 1.2 mg softgel lipid capsule orally once daily in the morning for up to 28 days.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive SAGE-718-matching placebo capsule orally once daily in the morning for up to 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAGE-718
2020
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
Sage TherapeuticsLead Sponsor
49 Previous Clinical Trials
11,681 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to soy lecithin or other ingredients in SAGE-718.I haven't been in a drug or device trial recently, except possibly as a placebo participant.You scored between 15 and 25 on the Montreal Cognitive Assessment, which means you have signs of thinking and memory problems (for participants with HD only).I have not taken any prohibited medications in the last 30 days.I was not diagnosed with juvenile Huntington's Disease before age 25.Your CAP score, which is calculated using a specific formula, is greater than 70.I have had surgery that affects my stomach or intestines.I can travel to the study center for my visits.I either have no family history of Huntington's disease or have a normal genetic test for it.My genetic test shows a CAG repeat of 36 or more.I agree not to use drugs or alcohol before study visits.Your level of daily functioning is not severely impaired, based on a specific assessment scale.My Huntington's disease did not start when I was a child.This criterion applies to everyone.Your total functional capacity score is between 6 and 13, indicating moderate functional impairment.This criterion is only for participants with Huntington's disease (HD).You scored 26 or higher on the MoCA test during the screening.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: SAGE-718
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Huntington's Disease Patient Testimony for trial: Trial Name: NCT05358821 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I sign up to participate in this research?
"80 participants are needed for this study and they must have a diagnosis of huntington disease. The age range that is being accepted in this trial is 25 to 65 years old."
Answered by AI
Is the age limit for this clinical trial set at 45 years or younger?
"This trial is only looking for patients that are aged 25 to 65. For those that don't meet this age requirement, there are 2 other clinical trials they could participate in."
Answered by AI
What is the margin of safety for SAGE-718?
"SAGE-718 falls into Phase 2 of clinical trials, so there is some data indicating that it is safe but none yet to suggest that the medication is effective. Our team scored it a 2."
Answered by AI
Is this study still looking for volunteers?
"The website clinicaltrials.gov indicates that this trial is still looking for participants. This particular study was first posted on June 22nd, 2022 and updated last on October 21st of the same year."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Sage Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Georgia
Florida
Alabama
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Need money for food. I want to help others with this disease. This disease runs in my family. I want to help find treatments.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Sage Investigational Site: < 24 hours
Average response time
- < 1 Day
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