SAGE-718 for Huntington's Disease

Recruiting at 21 trial locations

Overseen By Tatiana Oreshina

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sage Therapeutics

Must not be taking: Gene therapy, Antisense oligonucleotides

Disqualifiers: Alzheimer's, Parkinson's, Gastric surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 months

153 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial requires that you do not take any prohibited medications within 30 days before starting and during the study. However, it does not specify which medications are prohibited, so you should discuss your current medications with the study team.

Is SAGE-718 safe for humans?

SAGE-718 has completed early-stage clinical trials (phase 1) where it was tested in humans, and it is currently in phase 2 trials for cognitive impairment in Huntington's disease, suggesting it has shown a level of safety acceptable for further testing. ^{1 2 3 4 5}

How does the drug SAGE-718 differ from other treatments for Huntington's disease?

SAGE-718 is unique because it is being explored as a potential treatment for Huntington's disease, focusing on neuroprotective mechanisms that may slow disease progression, unlike current treatments that mainly address symptoms. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

My genetic test shows a CAG expansion of 40 or 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SAGE-718 from Day 1 up to Month 48

48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• SAGE-718

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort 3 (De Novo) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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.

Who Is Running the Clinical Trial?

Sage Therapeutics

Lead Sponsor

Trials

51

Recruited

11,000+

Founded

2010

Headquarters

Cambridge, USA

Known For

Brain Health Medicines

Top Products

ZURZUVAE (zuranolone), SAGE-324

Published Research Related to This Trial

Tiapride has been shown to effectively improve chorea symptoms in Huntington's Disease patients, with many experts preferring it as the first-line treatment, especially for those with behavioral symptoms.

The withdrawal of tiapride from the Dutch market has caused significant disruption for patients, with 50% needing to import the medication, highlighting its importance and lack of suitable alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Many Faces of Huntington's Chorea Treatment: The Impact of Sudden Withdrawal of Tiapride after 40 Years of Use and a Systematic Review. Feleus, S., van Schaijk, M., Roos, RAC., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

SAGE-718: A First-in-Class N-Methyl-d-Aspartate Receptor Positive Allosteric Modulator for the Potential Treatment of Cognitive Impairment. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Many Faces of Huntington's Chorea Treatment: The Impact of Sudden Withdrawal of Tiapride after 40 Years of Use and a Systematic Review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the dopaminergic stabilizer Pridopidine (ACR16) in patients with Huntington's disease. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Assessment of coenzyme Q10 tolerability in Huntington's disease. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of pridopidine in patients with Huntington's disease (PRIDE-HD): a phase 2, randomised, placebo-controlled, multicentre, dose-ranging study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A randomized, placebo-controlled trial of AFQ056 for the treatment of chorea in Huntington's disease. [2022]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Current therapeutic advances in patients and experimental models of Huntington's disease. [2019]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Novel targets for Huntington's disease: future prospects. [2020]

9. Denmark pubmed.ncbi.nlm.nih.gov

Olanzapine in Huntington's disease. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Therapeutic advances in Huntington's Disease. [2015]