At a glance
ClinicalIndex Comparison Record- ✓Clinically probable or clinically established Parkinson's disease meeting MDS 2015 criteria
- ✓Stable dosing of PD medications for ≥6 weeks prior to screening and stable through study
- ✓Prior exposure to PD medications (not treatment-naïve)
- ✓TETRAS-ADL subscale score >21
- ✕Hoehn & Yahr stage 5 (bed or wheelchair confinement without assistance)
- ✕Tremor only during OFF periods
- ✕Motor fluctuations or dyskinesia severity interfering with tremor assessment or unpredictable ON/OFF periods
- ✕Cognitive impairment (MoCA <22) or impairment preventing study completion or informed consent
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Placebo and Suvecaltamide for Parkinson Disease and Tremor. Completed, enrolled 169 participants across 37 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Matching placebo capsule(s) administered every day (QD) orally. Titration may proceed at a rate of 1 matching placebo capsule per day every 7 days as required for optimal efficacy and tolerability up to a maximum number of 3 matching placebo capsules per day.
Suvecaltamide capsule administered every day (QD) orally. Titration may proceed at a rate of 10 mg suvecaltamide per day every 7 days as required for optimal efficacy and tolerability up to a maximum dose of 30 mg suvecaltamide per day.