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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03436953
Study type Interventional
Source Jazz Pharmaceuticals
Contact
Status Withdrawn
Phase Phase 2
Start date December 2019
Completion date December 2020

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