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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avanir Pharmaceuticals
• Collaborator: Michael J. Fox Foundation for Parkinson's Research
• Treatments: Dextromethorphan; Levodopa; Quinidine; Quinidine gluconate

Criteria

Inclusion Criteria:

• Males and females 30 to 80 years of age, inclusive.

• Diagnosis of idiopathic PD meeting the United Kingdom Parkinson's disease Society Brain Bank criteria.

• Levodopa-induced dyskinesia present greater than 25% of the day as per MDS-UPDRS.

• Dyskinesia of at least moderate severity as per MDS-UPDRS

• Amantadine and Monoamine Oxidase (MAO) inhibitors must be discontinued at least three weeks prior to randomization.

• Subjects currently receiving anti-parkinsonian medications, including all Levodopa preparations are eligible provided they have been on a stable dose of these medications for at least 1 month prior to randomization.

• Concomitant use of antidepressants such as selective serotonin reuptake inhibitors are allowed, provided the dose has been stable for at least 1 month prior to randomization.

Exclusion Criteria:

• Subject had a prior surgery for PD except Deep Brain Stimulation (Deep Brain Stimulation must not have been performed within one year of screening)

• Hoehn and Yahr score of 5 when "off".

• Subject with Cognitive impairment and/or history of psychiatric manifestations or active hallucinations.

• Subjects with any history of complete heart block, QTc prolongation, or torsades de pointes.

• Subjects with any family history of congenital QT interval prolongation syndrome.

• Subjects with history of postural syncope, or any history of unexplained syncope within the last 12 months.

• Subjects with a history of substance and/or alcohol abuse within the past 2 years.