Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopa

Phase 2 Completed 31 enrolled Novartis

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the safety and efficacy of administration of AFQ056 in combination with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease patients.

Timeline

Start: 2007-10
Primary completion: 2008-05
Completion: —

Outcome

Mixed primary results

paper Lang-Fahn Activities of Daily Living Dyskinesia Scale, P = .021 [study 1] PMID 21484867 ↗

paper modified Abnormal Involuntary Movement Scale, P = .032 [study 2] PMID 21484867 ↗

paper No significant changes were seen from baseline on day 16 on the Unified Parkinson's Disease Rating Scale-part III in either study. PMID 21484867 ↗

Publications

Berg D, Godau J, Trenkwalder C, Eggert K, Csoti I, Storch A, Huber H, Morelli-Canelo M, Stamelou M, Ries V, Wolz M, Schneider C, Di Paolo T, Gasparini F, Hariry S, Vandemeulebroecke M, Abi-Saab W, Cooke K, Johns D, Gomez-Mancilla B. AFQ056 treatment of levodopa-induced dyskinesias: results of 2 randomized controlled trials. Mov Disord. 2011 Jun;26(7):1243-50. doi: 10.1002/mds.23616. Epub 2011 Apr 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mavoglurant	Small molecule	25 mg	Oral
Subject	Mavoglurant	Small molecule	150 mg	Oral