Suvecaltamide for Tremors in Parkinson's Disease
What You Need to Know Before You Apply
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.
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.12345
Who Is on the Research Team?
Jazz Study Director
Principal Investigator
Jazz Pharmaceuticals
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Titration and Optimization
Participants receive suvecaltamide or placebo with dose adjustments to find the optimal dose
Maintenance
Participants continue receiving the optimal dose of suvecaltamide or placebo
Safety Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Suvecaltamide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jazz Pharmaceuticals
Lead Sponsor
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