Suvecaltamide for Tremors in Parkinson's Disease

Recruiting in Palo Alto (17 mi)

+58 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Jazz Pharmaceuticals

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests suvecaltamide, a medication aimed at reducing severe tremors in adults with Parkinson's disease whose current treatments are not effective. The medication likely helps by calming the overactive nerves or muscles responsible for the tremors.

Research Team

Jazz Study Director

Principal Investigator

Jazz Pharmaceuticals

Eligibility Criteria

Adults with Parkinson's Disease who've had it for less than 5 years and experience moderate to severe tremor not controlled by current medications. They must be stable on their Parkinson's or tremor meds for at least 6 weeks, have a specific score on the TETRAS-ADL scale, and can't be bedridden or have unpredictable 'ON'/'OFF' periods.

Inclusion Criteria

I have been diagnosed with Parkinson's disease according to the MDS 2015 criteria.

You have significant tremors that affect your daily activities and have been assessed by a doctor to be moderate or severe.

I've been on a steady dose of my Parkinson's or tremor medication for at least 6 weeks.

Exclusion Criteria

You only have tremors when you are not taking your medication.

I don't use medications that could affect tremor evaluations on study days.

I have previously taken PD medication.

Treatment Details

Interventions

• Suvecaltamide (Other)

Trial Overview The trial is testing Suvecaltamide against a placebo over 17 weeks to see if it helps adults with Parkinson's reduce their persistent tremors. Participants will receive either the actual drug or a dummy pill without knowing which one they're getting.

Participant Groups

Group I: Sulvecaltamide Experimental Treatment 1 Intervention

Participants who will receive an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.

Group II: Placebo Placebo Group 1 Intervention

Participants who will receive a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.

Who Is Running the Clinical Trial?

Jazz Pharmaceuticals

Lead Sponsor

Trials

252

Recruited

35,100+

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland