SAGE-718 for Huntington's Disease

Recruiting in Palo Alto (17 mi)

+21 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sage Therapeutics

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new softgel capsule called SAGE-718 to see if it is safe for people with Huntington's Disease.

Eligibility Criteria

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.

Inclusion Criteria

I am between 25 and 65 years old.

I can travel to the study center and continue to do so for the study duration.

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

+6 more

Exclusion Criteria

Participants with confirmation of enrolment in the placebo arm of these investigational trials would not be excluded

I have had surgery that affects my stomach or intestines.

I have not been in any drug or device trials recently, nor have I had gene therapy.

+5 more

Participant Groups

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.

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 Month 48.

Group II: Cohort 2 (Gap Rollover)Experimental Treatment1 Intervention

Participants from studies 718-CIH-201 (NCT05107128) and 718-CIH-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 Month 48.

Group III: Cohort 1 (Direct Rollover)Experimental Treatment1 Intervention

Participants from studies 718-CIH-201 (NCT05107128) and 718-CIH-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 Month 48.