A 17-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Flexible-dosing, Parallel-group, Multicenter Study of the Efficacy and Safety of Suvecaltamide in the Treatment of Moderate to Severe Residual Tremor in Participants with Parkinson’s Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515177-94-00

Acronym

JZP385-202-01

Enrollment

132

Registered

2024-10-10

Start date

2023-06-21

Completion date

2024-11-01

Last updated

2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Brief summary

Evaluate the efficacy of suvecaltamide administered once daily for 17 weeks to improve functional and performance-based impairment due to tremor

Detailed description

Efficacy: Evaluate the efficacy of suvecaltamide administered once daily for 17 weeks to improve functional impairment due to tremor Safety: Incidence and severity of AEs as well as evaluation of safety laboratory assessments, vital signs, ECG results, C- SSRS and QUIP-RS

Interventions

DRUGPlacebo comprised of microcrystalline cellulose

DRUGused in JZP385-202-MCC placebo in the IMPD.

DRUGJZP385

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Evaluate the efficacy of suvecaltamide administered once daily for 17 weeks to improve functional and performance-based impairment due to tremor	—

Secondary

Measure	Time frame
Efficacy: Evaluate the efficacy of suvecaltamide administered once daily for 17 weeks to improve functional impairment due to tremor Safety: Incidence and severity of AEs as well as evaluation of safety laboratory assessments, vital signs, ECG results, C- SSRS and QUIP-RS	—

Countries

Germany, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026