ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease

Phase 2 Completed 83 enrolled Addex Pharma S.A.

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of the study is to evaluate the safety and tolerability of ADX48621 in Parkinson's disease patients following four weeks of dosing. The secondary objectives of the study include the evaluation of the efficacy of ADX48621 compared with placebo in reducing levodopa induced dyskinesia in patients with Parkinson's; the evaluation of the effect of ADX48621 on symptoms of Parkinson's disease and patient ability to function, and the evaluation of the effect of coadministration of ADX48621 on L-dopa efficacy.

Timeline

Start: 2011-04
Primary completion: 2012-02
Completion: 2012-02

Outcome

Met primary endpoint

release “Dipraglurant met the primary objective of the study by exhibiting a good safety and tolerability profile.” addextherapeutics.com ↗

release “In the presentation at the AAN conference, Professor Tison reported that the study met the primary objectives of safety and tolerability at both 50 and 100mg doses” addextherapeutics.com ↗

release “In a double-blind, placebo-controlled, US and European Phase 2 study in PD-LID, data showed that dipraglurant met the primary objective of the study” addextherapeutics.com ↗

release “In a double-blind, placebo-controlled, US and European Phase II study in PD-LID, data showed that dipraglurant met the primary objective” addextherapeutics.com ↗

release “Dipraglurant significantly reduced peak dose dyskinesia (modified Abnormal Involuntary Movement Scale) on day 1 (50 mg, 20%; P = 0.04)” addextherapeutics.com ↗

Publications

McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dipraglurant	Small molecule	100 mg	Oral