NCT03436953

A Phase 2 Study of CX-8998 in Adults With Tremor Associated With Parkinson's Disease

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of CX-8998 for Tremor Associated With Parkinson's Disease

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, multicenter, double-blind, placebo-controlled, parallel-group study consisting of a screening period of up to 4 weeks, a 4 week randomized double-blind, dose-titration treatment period, followed by a 1 week safety follow-up period after the last dose of study medication, and a scheduled follow-up safety telephone call one week later.

Detailed description

This is a Phase 2, multicenter, double-blind, placebo-controlled, parallel-group study consisting of a screening period of up to 4 weeks, a 4 week randomized double-blind, dose-titration treatment period, followed by a 1 week safety follow-up period after the last dose of study medication, and a scheduled follow-up safety telephone call one week later. Subjects will be randomized 1:1 to one of two treatment groups. Group A will receive titrating doses of CX-8998 up to 10 mg BID and Group B will receive placebo. Subjects will participate for a total of up to 12 weeks, including screening, the 4-week treatment period and follow-up.

Conditions

• Parkinson's Disease
• Tremor

Interventions

Type	Name	Description
DRUG	CX-8998	T-type calcium channel blocker
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-09-01
• Completion: 2020-12-01
• First posted: 2018-02-19
• Last updated: 2021-05-28

Regulatory

• FDA-regulated drug study