← Back to Search

Other

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

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
Select...
You have significant tremors that affect your daily activities and have been assessed by a doctor to be moderate or severe.
Select...
I have been diagnosed with Parkinson's disease according to the MDS 2015 criteria.
Select...
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:
Select...
I have had or am planning to have surgery for Parkinson's disease.
Select...
I have not had botulinum toxin injections in areas affected by tremor in the last 6 months.
Select...
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Parkinson's Disease include levodopa, dopamine agonists, MAO-B inhibitors, and anticholinergics. Levodopa is converted to dopamine in the brain, replenishing the diminished neurotransmitter and improving motor symptoms. Dopamine agonists mimic dopamine by stimulating dopamine receptors directly. MAO-B inhibitors prevent the breakdown of dopamine, increasing its availability. Anticholinergics reduce the activity of acetylcholine, helping to balance neurotransmitter levels. Suvecaltamide, a calcium channel modulator, is being studied for its potential to reduce tremors by stabilizing neuronal activity. These mechanisms are crucial for PD patients as they aim to restore the balance of neurotransmitters, alleviate motor symptoms, and improve quality of life.
A quantitative study of levodopa-induced dyskinesia in Parkinson's disease.New pharmacological options for treating advanced Parkinson's disease.

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
249 Previous Clinical Trials
34,743 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
~33 spots leftby Dec 2024