Sulvecaltamide for Parkinson's Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Parkinson's Disease+1 MoreSuvecaltamide - Drug
Eligibility
40 - 80
All Sexes
What conditions do you have?
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Study Summary

This is a 17-week double-blind, placebo-controlled, randomized, flexible-dosing, parallel-group, multicenter study designed to evaluate the efficacy and safety of suvecaltamide for the treatment of moderate to severe residual tremor in adult participants with Parkinson's disease (PD). The target population represents participants who have tremor that is not adequately controlled by PD medications and that interferes with their activities of daily living (ADL) and/or with their performance of tasks.

Eligible Conditions
  • Parkinson's Disease
  • Tremor

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Week 17 post-dose.

Week 17
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)
Change from Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score
Change from Baseline to Week 17 on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Tremor Score
Proportion of Participants Who Improved (≥ 1-point improvement) from Baseline to Week 17 on the Clinical Global Impression of Severity (CGI-S)
Proportion of participants who improved (≥ 1 point) from Baseline to Week 17 on the Patient's Global Impression of Severity (PGI-S)
Week 17 post-dose.
Proportion of Participants who were Much Improved on the Clinician's Global Impression of Change (CGI-C) at Week 17
Proportion of participants who were much improved on the Patient's Global Impression of Change (PGI-C) at Week 17

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Sulvecaltamide
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

160 Total Participants · 2 Treatment Groups

Primary Treatment: Sulvecaltamide · Has Placebo Group · Phase 2

Sulvecaltamide
Drug
Experimental Group · 1 Intervention: Suvecaltamide · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 17 post-dose.

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
218 Previous Clinical Trials
30,109 Total Patients Enrolled
Jazz Study DirectorStudy DirectorJazz Pharmaceuticals

Eligibility Criteria

Age 40 - 80 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants must be individually optimized on PD medications for the treatment of other cardinal signs of PD (bradykinesia, rigidity) per the judgment of the investigator
You have tremors that are severe enough to interfere with your ability to perform activities of daily living.
You have a score of 2 or more on item 6 of The Essential Tremor Assessment Rating Scale, Performance Subscale (TETRAS-PS).