CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 95 enrolled
Drug / intervention
CX-8998 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03101241
NCT03101241Phase 2Completed

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of CX-8998 for Essential Tremor

Jazz Pharmaceuticals·interventional·Posted Apr 5, 2017·Updated Nov 23, 2021

In Brief

A Phase 2 clinical trial evaluating CX-8998 and Placebo for Essential Tremor. Completed, enrolled 95 participants across 22 sites.

Detailed Summary

This is a multicenter, double-blind, placebo-controlled, parallel-group study consisting of a screening period of up to 4 weeks (with the exception of participants on primidone at baseline who will be allowed 6 weeks of screening to allow for safe discontinuation). Screening results from all patients meeting the eligibility requirements will be further assessed by the sponsor medical personnel for final approval of suitability for inclusion in the study. Randomized participants will enter a 4 week double-blind dose-titration treatment period, followed by a 1 week safety follow-up period following the last dose of study medication, and a scheduled follow-up safety telephone call one week later.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 5, 2017
Enrollment StartAug 29, 2017
Primary CompletionJul 16, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.2 years ago

Interventions

CX-8998drug

T-type calcium channel blocker

Placebodrug

Placebo comparator