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 a new treatment called suvecaltamide to manage tremors in people with Parkinson's disease. The researchers aim to determine if this medication can effectively and safely reduce tremors not well-controlled by current Parkinson's medications and that interfere with daily activities. Participants will receive either suvecaltamide or a placebo (a substance with no active medication) to compare results. The trial seeks individuals diagnosed with Parkinson's disease who experience moderate to severe tremors that disrupt daily life despite stable medication use. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to the early-stage development of a potentially beneficial therapy.
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.
Is there any evidence suggesting that suvecaltamide is likely to be safe for humans?
Research has shown that suvecaltamide has generally been well-tolerated in past studies. No new safety issues emerged, with side effects similar to those previously observed. Although one study did not meet its main goal, it still demonstrated some symptom improvement and confirmed the treatment's tolerability. This suggests that suvecaltamide may be a safe option for those considering participation in clinical trials.12345
Why do researchers think this study treatment might be promising for Parkinson's disease?
Unlike the standard treatments for Parkinson's disease tremors, which often include medications like levodopa or dopamine agonists, Suvecaltamide is unique because it targets a different mechanism. Most treatments aim to increase dopamine levels, but Suvecaltamide focuses on modulating specific receptors in the brain that are thought to play a role in tremor control. This innovative approach has researchers excited because it could offer relief for patients who don't respond well to current therapies, providing a new avenue for managing tremors more effectively.
What evidence suggests that suvecaltamide might be an effective treatment for tremors in Parkinson's disease?
Research has shown that suvecaltamide might help reduce tremor symptoms in people with Parkinson's disease. In this trial, participants will receive either suvecaltamide or a placebo. Previous studies did not find a significant difference in tremor reduction compared to a placebo, which contains no active medicine. However, some patients experienced improvements. The treatment was generally safe, with no major side effects reported. This suggests that suvecaltamide could help with tremors, but further research is needed to confirm its effectiveness.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