Suvecaltamide for Tremors in Parkinson's Disease

Recruiting at 58 trial locations

Overseen By Clinical Trial Disclosure & Transparency

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Jazz Pharmaceuticals

Must be taking: PD medications

Must not be taking: CYP3A4 inducers, inhibitors

Disqualifiers: Pregnancy, Cognitive impairment, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

169 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

Participants must be on a stable dosing regimen of their Parkinson's disease and/or other tremor medications for at least 6 weeks before the trial and should not change these medications during the study. Some medications, like those affecting CYP3A4, proton pump inhibitors, and certain PRN medications, must be stopped before the trial.

What data supports the effectiveness of the drug Suvecaltamide for tremors in Parkinson's disease?

The research does not provide direct evidence for Suvecaltamide, but it mentions that dopaminergic drugs, like levodopa and dopamine agonists, are effective in reducing tremors in Parkinson's disease, with improvements of 30 to 50% in tremor ratings. This suggests that treatments targeting dopamine pathways can be beneficial for tremor management. ^{1 2 3 4 5}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Dose Titration and Optimization

Participants receive suvecaltamide or placebo with dose adjustments to find the optimal dose

5 weeks

Maintenance

Participants continue receiving the optimal dose of suvecaltamide or placebo

12 weeks

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Suvecaltamide

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

Findings from Research

Levodopa and dopamine agonists both provide a mean improvement of 30 to 50% in reducing tremor severity in patients with Parkinson's disease, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS).

Dopamine agonists are particularly effective for newly diagnosed patients with tremor-predominant Parkinson's disease and can also benefit advanced patients whose tremor does not respond to levodopa or anticholinergics, highlighting the need for a tailored approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tremor and dopamine agonists. Elble, RJ.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Noninvasive options for 'wearing-off' in Parkinson's disease: a clinical consensus from a panel of UK Parkinson's disease specialists. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Levodopa/DDCI and entacapone is the preferred treatment for Parkinson's disease patients with motor fluctuations in routine practice: a retrospective, observational analysis of a large French cohort. [2015]

3. England pubmed.ncbi.nlm.nih.gov

New levodopa therapeutic strategies. [2015]

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

Tremor and dopamine agonists. [2019]

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

Randomized, Controlled Study of Opicapone in Japanese Parkinson's Patients with Motor Fluctuations. [2021]