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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be at least 25 years old, but not older than 65 years of age at Screening
Genetically confirmed disease with cytosine-adenine-guanine (CAG) expansion ≥40
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 13 months
Awards & highlights
Study Summary
This trial will assess the safety of a new capsule for Huntington's Disease, to see if it's tolerable for patients.
Who is the study for?
This trial is for adults aged 25-65 with genetically confirmed Huntington's Disease, a CAG expansion ≥40, and specific cognitive or functional scores. Participants must avoid drugs of abuse, alcohol before visits, and be able to travel to the study center. They should not have juvenile HD features or other neurodegenerative conditions.Check my eligibility
What is being tested?
The trial is testing SAGE-718 softgel capsules' safety and tolerability in those with Huntington's Disease. It aims to see how well participants handle the treatment over time.See study design
What are the potential side effects?
Specific side effects are not listed but will focus on any adverse reactions related to SAGE-718 capsules which include its components like soy lecithin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 25 and 65 years old.
Select...
My genetic test shows a CAG expansion of 40 or more.
Select...
I do not have juvenile Huntington's disease.
Select...
My CAP score is 90 or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 13 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
Number of Participants Who Withdrew Due to Adverse Events (AEs)
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs
+1 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
3Treatment groups
Experimental Treatment
Group I: Cohort 3 (De Novo)Experimental Treatment1 Intervention
Participants who were not previously included in any SAGE-718 clinical study. Participants will receive Sage-718 from Day 1 up to Day 365.
Group II: Cohort 2 (Gap Rollover)Experimental Treatment1 Intervention
Participants from studies 718-CIH-201 (NCT05107128)/202 (NCT05358821) who will sign the informed consent for study 718-CIH-301 after a gap of >7 days after the last day of the corresponding parent study. Participants will receive Sage-718 from Day 1 up to Day 365.
Group III: Cohort 1 (Direct Rollover)Experimental Treatment1 Intervention
Participants from studies 718-CIH-201 (NCT05107128)/202 (NCT05358821) who will sign the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study. Participants will receive Sage-718 from Day 1 up to Day 365.
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
11,461 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 25 and 65 years old.I have had surgery that affects my stomach or intestines.I can travel to the study center and continue to do so for the study duration.I have not been in any drug or device trials recently, nor have I had gene therapy.You are currently experiencing serious side effects from the previous study.I am allergic to soy lecithin or other components in SAGE-718.I have not taken any prohibited medications in the last 30 days.I have a neurodegenerative condition like Alzheimer's, but not Huntington's Disease.My genetic test shows a CAG expansion of 40 or more.I agree to not use drugs or alcohol before study visits.You have a Unified Huntington's Disease Rating Scale (UHDRS) -Total Functional Capacity (TFC) score of 13 or lower, or a Montreal Cognitive Assessment (MoCA) score of 25 or lower.I do not have juvenile Huntington's disease.My CAP score is 90 or higher.You have already participated in studies 718-CIH-201 or 718-CIH-202, or you meet the requirements to be in the de novo cohort.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 (Direct Rollover)
- Group 2: Cohort 2 (Gap Rollover)
- Group 3: Cohort 3 (De Novo)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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: NCT05655520 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project accept participants who are older than twenty?
"The parameters for this research necessitates that potential participants must be between 25 and 65 years of age. There are 1 studies enrolling minors, while 28 trials can accommodate older individuals."
Answered by AI
To what degree is Cohort 3 (De Novo) reliable for patient care?
"Our team has determined that Cohort 3 (De Novo) is reasonably safe and assigned it a rating of three. This conclusion was drawn from prior clinical data affirming its efficacy and safety in multiple trials."
Answered by AI
Could you provide an estimate of the participants involved in this medical investigation?
"Affirmative. According to clinicaltrials.gov, this medical research is presently in the process of finding participants. This trial was initially published on December 14th 2022 and most recently updated on January 13th 2023. Three sites are aiming to recruit a total of 300 patients for the experiment."
Answered by AI
What criteria must individuals meet in order to qualify for this clinical investigation?
"Patients between 25 and 65 with a diagnosis of Huntington's disease can apply for admittance to this clinical trial, which is set to enrol 300 applicants."
Answered by AI
Are there current opportunities to enroll in this clinical experiment?
"Clinicaltrials.gov reveals that this clinical study is actively seeking participants, having first been posted on December 14th 2022 and last updated on January 13th 2023."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Alabama
What site did they apply to?
Sage Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I don't have a job n I need money for food . Thank u for your time e God bless.
PatientReceived 2+ prior treatments
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