Last updated on November 2017

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


Brief description of study

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

Detailed Study Description

This is a double-blind, placebo-controlled, parallel-group study. Subjects will be randomized to one of two treatment groups. Group A will receive CX-8998 and Group B will receive placebo. Subject randomization will be stratified by concomitant primidone use and site type (sub-study vs non sub-study).

Tremor will be assessed via The Essential Tremor Rating Assessment Scale (TETRAS) and accelerometry. In order to reduce rater bias, all subjects will be videotaped during the TETRAS performance scale testing according to a consistent script. The videotapes will be rated in a blinded manner. A subset of subjects will participate in an electroencephalography (EEG) and magnetoencephalography (MEG) sub-study to record power-spectral brain activity in specific neuro-anatomical locations and coherence with movement measures.

Subjects will be screened up to one month prior to initiation of dosing. At Baseline, subjects will undergo safety and tremor assessments prior to dosing, will receive their first dose of study drug and will be monitored for safety for one hour following dosing. For one week subjects will receive 4 mg (or matching placebo) twice daily. Subjects will return to the clinic on Day 8 for safety monitoring and dose up-titration to 6 mg (or matching placebo) twice daily. At Day 15 (Week 3) subjects will return to clinic for safety and efficacy assessments and final dose up-titration to 8 mg (or matching placebo) twice daily. The final efficacy visit will occur at Day 28 (Week 4). A final safety visit will occur at Day 35 (Week 5).

Clinical Study Identifier: TX82244

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Jessica Shaw

University of South Florida -Morsani Center for Advanced Healthcare
Tampa, FL USA
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