Trial intelligence / Profile preview

T-CALM: Suvecaltamide for Essential Tremor

NCT03101241Phase 2

Key facts

Status
Completed
Start
Aug 2017
Primary completion
Jul 2018
Countries
1
Modality
Small Molecules
Conditions
essential tremor (ET)
01

Overview

Phase 2, randomised, double-blind trial in essential tremor (ET) comparing CX-8998 with Placebo (2 arms). Primary endpoint: The Essential Tremor Rating Assessment Scale Performance Subscale Total Score at Day 28. Started Aug 2017; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • CX-8998

    Suvecaltamide titrated to 10 mg BID

  • Placebo

    Matching Placebo

03

Who it enrols

Adults 18-75 with definite or probable essential tremor, TETRAS score >= 15, and tremor severity >= 2. One concomitant anti-tremor med allowed (except primidone).

04

Endpoints

Primary

  • The Essential Tremor Rating Assessment Scale Performance Subscale Total Score

Secondary

  • The Essential Tremor Rating Assessment Scale Activities of Daily Living Subscale Score

  • Kinesia ONE Score

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