Suvecaltamide for Tremors in Parkinson's Disease

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CT
Overseen ByClinical Trial Disclosure & Transparency
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Jazz Pharmaceuticals
Must be taking: PD medications
Prior Safety DataThis treatment has passed at least one previous human trial

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?

JS

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

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.
See 2 more

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.
See 17 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SulvecaltamideExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jazz Pharmaceuticals

Lead Sponsor

Trials
252
Recruited
35,100+
Bruce C. Cozadd profile image

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin profile image

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Published Research Related to This Trial

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

Citations

NCT05642442 | A Study of Suvecaltamide in Adults With ...Participants will be randomized 1:1 to receive suvecaltamide or placebo and stratified by the Essential Tremor Rating Scale (TETRAS) composite outcome score (≤ ...
Jazz Pharmaceuticals Provides Update on Phase 2b Trial of ...Suvecaltamide did not achieve statistical significance at 30mg versus placebo on the primary endpoint of change from baseline to week 12 on the ...
Design of a Phase 2 Study of Suvecaltamide in Moderate ...This study will evaluate the efficacy of suvecaltamide on the functional impact of PDT using a composite of The Essential Tremor Rating Assessment Scale ( ...
Jazz's Suvecaltamide Fails to Meet Primary End Point in ...Suvecaltamide did not meet the primary endpoint in the phase 2b trial but showed numeric improvements and was well-tolerated.
Suvecaltamide for Tremors in Parkinson's DiseaseLevodopa 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 ...
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