Trial intelligence / Profile preview

Mavoglurant for L-dopa Induced Dyskinesias in PD

NCT00986414Phase 2

Key facts

Status: Completed
Start: Sep 2009
Primary completion: Dec 2010
Countries: 8
Sponsor: Novartis
Modality: Small Molecules

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

Overview

Phase 2, randomised, double-blind trial of mavoglurant in levodopa-induced dyskinesia (LID) (6 arms), sponsored by Novartis. Primary endpoint: modified Abnormal Involuntary Movement Scale total score at 12 weeks. Started Sep 2009; status: completed.

Design

6 arms

Study design: RandomizedDouble-blind

AFQ056 10mg
Mavoglurant 10mg
AFQ056 25mg
Mavoglurant 25mg
AFQ056 50mg
Mavoglurant 50mg
AFQ056 75mg
Mavoglurant 75mg
AFQ056 100mg
Mavoglurant 100mg
Placebo
Placebo

Who it enrols

Outpatients with Parkinson's disease treated with L-Dopa experiencing dyskinesias for at least three months. Excludes patients with surgical treatment for PD, recent cancer, or unstable disease.

Endpoints

Primary

modified Abnormal Involuntary Movement Scale total score12 weeks

Secondary

26-Item Parkinson Disease Dyskinesia Scale total score12 weeks
Clinician Global Impression of Change12 weeks
Patient Global Impression of Change12 weeks
Unified Parkinson's Disease Rating Scale Part IV12 weeks
Unified Parkinson's Disease Rating Scale Part III12 weeks

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