Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients

Phase 2 Completed 14 enrolled Avanir Pharmaceuticals Michael J. Fox Foundation for Parkinson's Research · collab

RandomizedCrossoverTriple-blindTreatment

Summary

To evaluate the efficacy, safety, and tolerability of AVP-923 capsules containing 45 mg dextromethorphan and 10 mg quinidine (AVP-923-45) compared to placebo for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).

Timeline

Start: 2013-10-16
Primary completion: 2015-02-05
Completion: 2015-02-05

Outcome

Missed primary endpoint

registry analysis (superiority test); AVP-923-45 vs Placebo; p = 0.1907; Mean Difference (Final Values) -83.4 (95% CI -215.02 to 48.23); ANOVA NCT01767129 ↗

Publications

Results Fox SH, Metman LV, Nutt JG, Brodsky M, Factor SA, Lang AE, Pope LE, Knowles N, Siffert J. Trial of dextromethorphan/quinidine to treat levodopa-induced dyskinesia in Parkinson's disease. Mov Disord. 2017 Jun;32(6):893-903. doi: 10.1002/mds.26976. Epub 2017 Mar 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dextromethorphan	Unknown	45 mg	—
Background	Quinidine	Small molecule	10 mg	—