NCT01767129

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

A Phase 2a, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Avanir Pharmaceuticals · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Proof-of-concept phase 2a, double-blind, randomized, placebo-controlled, crossover study.

Conditions

• Dyskinesia
• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	AVP-923-45	One capsule twice daily for 14 days
DRUG	Placebo	One capsule twice daily for 14 days

Timeline

• Start date: 2013-10-16
• Primary completion: 2015-02-05
• Completion: 2015-02-05
• First posted: 2013-01-14
• Last updated: 2022-04-29
• Results posted: 2022-04-29

Locations

3 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study