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Clinical trial

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

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Last updated:1st Dec 2019
Identifier: NCT03436953

Brief 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.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of CX-8998 for Tremor Associated With Parkinson's Disease
Estimated Study Start Date: December 2019
Estimated Primary Completion Date: September 2020
Estimated Study Completion Date: December 2020

Arms:
- Experimental:
CX-8998 T-type calcium channel blocker
- Placebo Comparator: Comparator

Category Value
Date last updated at source 2019-04-08
Study type(s) Interventional
Expected enrolment 60
Study start date 2019-12-01
Estimated primary completion date 2020-09-01

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