SAGE-324 for Essential Tremor

Recruiting at 4 trial locations

Overseen By Carrie Vaudreuil, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sage Therapeutics

Must be taking: Propranolol

Must not be taking: Tremorgenic drugs

Disqualifiers: Substance abuse, Brain procedures, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

160 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication to see how well it reduces arm and hand tremors in people with essential tremor. The goal is to find the most effective dose that helps calm the brain's overactive signals causing the tremors.

Will I have to stop taking my current medications?

You will need to stop taking medications for essential tremor, except for propranolol, at least 14 days or 5 half-lives before starting the trial. You can resume these medications after Day 97 of the study.

Eligibility Criteria

This trial is for adults with Essential Tremor (ET) that's lasted at least 3 years. Participants must be willing to stop their ET medications before starting the study, except propranolol if it's been taken steadily. They can't have other neurological issues or use certain treatments like the Cala Trio bracelet, and they shouldn't have a history of substance abuse or dependence.

Inclusion Criteria

My arm strength score is 6 or more.

I am willing to stop my essential thrombocythemia (ET) treatment before starting the trial medication.

I do not have other major nerve system symptoms like uncontrolled movements or balance issues.

Exclusion Criteria

I have been using the Cala Trio bracelet for my ET for at least two weeks.

I am currently taking propranolol for a condition that is not essential tremor.

I haven't taken any new tremor-causing drugs or experienced alcohol withdrawal in the last 14 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SAGE-324 or placebo, with dose adjustments over 90 days

13 weeks

Regular visits for dose adjustments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SAGE-324

Trial Overview The trial tests SAGE-324 against a placebo to see how different doses affect arm tremors in people with ET. It looks at whether one dose works better than another when no other tremor medications are used.

Participant Groups

Group I: SAGE-324 60 mg Experimental Treatment 1 Intervention

Participants will receive SAGE-324: 15 mg, 30 mg, 45 mg, and 60 mg, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324, 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, oral tablets, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324, 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.

Group II: SAGE-324 30 mg Experimental Treatment 1 Intervention

Participants will receive SAGE-324, 30 mg, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324, 30 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324, 30 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.

Group III: SAGE-324 15 mg Experimental Treatment 1 Intervention

Participants will receive SAGE-324, 15 mg, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324, 15 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324, 15 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.

Group IV: SAGE-324 Matched Placebo Placebo Group 1 Intervention

Participants will receive SAGE-324 matched placebo, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324 matched placebo, oral tablets, once daily (QD), in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324 matched placebo, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 milligrams (mg) of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.

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

Biogen

Industry Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada