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Suvecaltamide for Tremors in Parkinson's Disease

Phase 2
Recruiting
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants have moderate to severe impairment associated with tremor at both the screening and baseline visits, as determined by all the following: A score of > 21 on The Essential Tremor Assessment Rating Scale, Activities of Daily Living (TETRAS-ADL) subscale; and Clinician Global Impression of Severity (CGI-S) rating of tremor severity of > 2 (at least moderate for participant's ability to function)
Diagnosis of clinically probable or clinically established Parkinson's disease (PD) meeting the Movement Disorder Society (MDS) 2015 criteria
Must not have
Prior or planned surgical intervention to treat PD, including but not limited to magnetic resonance-guided focused ultrasound thalamotomy, deep brain stimulation, ablative thalamotomy, and gamma knife thalamotomy
Botulinum toxin injection in the 6 months before screening or planned use at any time during the study. Note: Use of botulinum toxin for other reasons (eg, cosmetic, excessive salivation, dystonia) is permitted as long as the location of use is anatomically distinct from the region with tremor
Timeline
Screening 28 days
Treatment 17 weeks
Follow Up 2 weeks
Awards & highlights

Study Summary

This trial will study an experimental drug to see if it helps treat tremors in people with Parkinson's that can't be controlled with other drugs.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of Suvecaltamide are not listed here, common ones in trials may include nausea, dizziness, sleep issues, digestive changes, and potential interactions with other drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have significant tremors that affect your daily activities and have been assessed by a doctor to be moderate or severe.
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I have been diagnosed with Parkinson's disease according to the MDS 2015 criteria.
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I've been on a steady dose of my Parkinson's or tremor medication for at least 6 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had or am planning to have surgery for Parkinson's disease.
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I have not had botulinum toxin injections in areas affected by tremor in the last 6 months.
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I can stop using proton pump inhibitors 2 weeks before and during the study.

Timeline

Screening ~ 28 days
Treatment ~ 17 weeks
Follow Up ~2 weeks
This trial's timeline: 28 days for screening, 17 weeks for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score
Secondary outcome measures
Change from Baseline to Week 17 on TETRAS total score (TETRAS-ADL + TETRAS-PS)
Change from Baseline to Week 17 on The Essential Tremor Rating Scale, Activities of Daily Living Subscale (TETRAS-ADL)
Change from Baseline to Week 17 on The Essential Tremor Rating Scale, Performance Subscale (TETRAS-PS)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SulvecaltamideExperimental Treatment1 Intervention
Participants who will receive an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.
Group II: PlaceboPlacebo Group1 Intervention
Participants who will receive a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,125 Total Patients Enrolled
Jazz Study DirectorStudy DirectorJazz Pharmaceuticals
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Suvecaltamide (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05642442 — Phase 2
Parkinson's Disease Research Study Groups: Placebo, Sulvecaltamide
Parkinson's Disease Clinical Trial 2023: Suvecaltamide Highlights & Side Effects. Trial Name: NCT05642442 — Phase 2
Suvecaltamide (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05642442 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining in this clinical research?

"According to the information found on clinicaltrials.gov, this research project is no longer recruiting participants. It was initially posted in December of 2022 and last modified at the end of November that same year; yet, there are 529 other trials actively searching for volunteers presently."

Answered by AI

Do I meet the criteria for joining this research endeavor?

"This medical trial is recruiting 160 individuals afflicted with tremor, aged between 40 and 80. The prerequisites for participation are as follows: male/female patients from 40-80 years of age, BMI measurements ranging from 17 to 45kg/m2 at screening, a diagnosis of idiopathic Parkinson's disease that meets Movement Disorder Society (MDS) 2015 criteria within the last 5 years, an optimized therapeutic effect on PD medications when no further adjustments can be made without inducing intolerable side effects, stable dosing regimen of permitted tremors or PD medications for 6 weeks prior to screening and throughout the duration of the study, a score >"

Answered by AI

Does the protocol for this trial extend to those of more advanced age?

"This clinical trial is recruiting adults aged 40 and over, with the upper age limit set at 80 years."

Answered by AI

Has Sulvecaltamide been granted clearance by the Federal Drug Administration?

"Sulvecaltamide's safety has been partially established, resulting in a score of 2. As this is a phase 2 clinical trial, there are no existing data confirming its efficacy."

Answered by AI

How many healthcare facilities have been recruited for this experiment?

"The clinical trial is enrolling patients at 18 different medical sites, such as the University of Cincinnati in Ohio, Woodland Research Northwest in Arkansas, and Keck School of Medicine at the University of Southern California."

Answered by AI

Who else is applying?

What site did they apply to?
Keck School of Medicine of the University of Southern California
The Nene and Jamie Koch Comprehensive Movement Disorders Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease
2022. "A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05642442.
All > Honolulu
~0 spots leftby May 2024
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