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SAGE-718 for Huntington's Disease

Phase 2
Recruiting
Research Sponsored by Sage Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Genetically confirmed disease with huntingtin gene CAG expansion ≥36
Score <26 on the Montreal Cognitive Assessment (MoCA) at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 112 days
Awards & highlights

Study Summary

This trial will study whether SAGE-718 can improve cognition in people with Huntington's disease.

Who is the study for?
This trial is for individuals with genetically confirmed Huntington's Disease, who have moderate functional capacity and mild cognitive impairment. They must be able to visit the study center regularly and bring a reliable adult partner if possible. People can't join if they've been in certain drug trials recently or have other neurodegenerative conditions.Check my eligibility
What is being tested?
The trial is testing SAGE-718's impact on cognitive function in Huntington's patients compared to a placebo (a substance with no therapeutic effect). Participants will randomly receive either SAGE-718 or the placebo to assess differences in their cognitive performance.See study design
What are the potential side effects?
Potential side effects of SAGE-718 are not specified here, but generally could include reactions at the site of administration, general discomforts like headaches or nausea, and possibly effects related to cognition since it targets brain function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My genetic test shows I have Huntington's disease.
Select...
My cognitive test score was below 26.
Select...
I do not have juvenile Huntington's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 112 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 112 days for reporting.

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 the Huntington's Disease Cognitive Assessment Battery (HD-CAB) Composite Score
Secondary outcome measures
Change From Baseline in the UHDRS - Total Motor Score (TMS)
Change From Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) - Independence Scale
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

Side effects data

From 2022 Phase 2 trial • 18 Patients • NCT04476017
9%
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, once daily for 84 days.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo, once daily for 84 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
11,583 Total Patients Enrolled

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05107128 — Phase 2
Huntington's Disease Research Study Groups: Placebo, SAGE-718
Huntington's Disease Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05107128 — Phase 2
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05107128 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple locales partaking in this experiment across the state?

"Currently, 23 different medical centers are participating in the trial. These sites span from Philadelphia to Iowa City and Chicago, as well as other locales. Therefore, it is beneficial for prospective participants to choose an enrolment site that is nearest them so they can reduce their travel burden."

Answered by AI

Are there any opportunities for volunteers to participate in this research endeavor?

"Yes, current records on clinicaltrials.gov confirm that this medical trial is actively recruiting participants since its inaugural posting on February 10th 2022 and most recently amended on November 11th 2022. The study requires 178 patients across 23 sites to complete the research."

Answered by AI

What is the enrollment rate of people participating in this research?

"Affirmative. Clinicaltrials.gov has information suggesting that this clinical experiment is currently searching for eligible patients, which was first posted on February 10th 2022 and last updated November 11th 2022. 178 participants are needed between 23 centres."

Answered by AI

Has SAGE-718 obtained authorization from the FDA?

"Our team believes SAGE-718 to be relatively safe, garnering a score of 2. While there is evidence that the drug may be secure, no research yet indicates its efficacy."

Answered by AI

Am I eligible to partake in this medical investigation?

"To be eligible for this trial, applicants must have Huntington's disease and fall within the age range of 25 to 65. Presently, 178 participants are required."

Answered by AI

Does the age of 35 represent a cutoff for possible participation in this research endeavor?

"This medical trial has an age range requirement of 25 to 65 years old for participation. Moreover, there are two separate studies available for those under 18 and 32 additional avenues available for elderly patients over the age of 65."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Sage Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)
2022. "A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05107128.
All > Huntingtons Disease > Huntington Disease
~38 spots leftby Dec 2024
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