Trial intelligence / Profile preview

EASED: ADS-5102 in Levodopa-Induced Dyskinesia

NCT01397422Phase 3

Key facts

Status: Completed
Start: Jul 2011
Primary completion: May 2013
Countries: 1
Modality: Small Molecules

Drugs: amantadine
Conditions: levodopa-induced dyskinesia (LID)

Overview

Phase 3, randomised, double-blind trial of amantadine in levodopa-induced dyskinesia (LID) (4 arms). Primary endpoint: Unified Dyskinesia Rating Scale Total Score at 8 weeks. Started Jul 2011; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

Placebo
Placebo capsules once daily
Low dose ADS-5102
260 mg ADS-5102 once daily
Mid-dose ADS-5102
340 mg ADS-5102 once daily
High dose ADS-5102
420 mg ADS-5102 once daily

Who it enrols

Patients with Parkinson's disease on a stable regimen of antiparkinson's medications including levodopa, experiencing troublesome dyskinesia.

Endpoints

Primary

Unified Dyskinesia Rating Scale Total Score8 weeks

Secondary

Fatigue Severity Score8 weeks
Unified Dyskinesia Rating Scale Objective Score8 weeks
ON Time Without Troublesome Dyskinesia8 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale Combined Score8 weeks
Clinician's Global Impression of Change8 weeks

Results

Primary endpoints met

Beyond the preview

Go deeper on NCT01397422.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01397422.