Dyskinesia | Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients
Dyskinesia research study
What is the primary objective of this study?
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).
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:AVP-923-45One capsule twice daily for 14 days
Drug:PlaceboOne capsule twice daily for 14 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
AVP-923-45AVP-923-45 twice daily for 14 days
PlaceboPlacebo twice a day for 14 days
Start Date: July 2013
Completed Date: April 2015
Phase: Phase 2
Primary Outcome: Unified Dyskinesia Rating Scale (UDysRS), part 3
Secondary Outcome: UDysRS, part 4
Study sponsors, principal investigator, and references
Lead Sponsor: Avanir Pharmaceuticals
Collaborator: Michael J. Fox Foundation for Parkinson's Research