Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients
Information source: Avanir Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyskinesia; Parkinson's Disease
Intervention: AVP-923-45 (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Avanir Pharmaceuticals
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).
Clinical Details
Official title: 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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Unified Dyskinesia Rating Scale (UDysRS), part 3
Secondary outcome: UDysRS, part 4Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III-motor score Bradykinesia MDS-UPDRS part I, II, and IV UDysRS part 1 and 2 PD Motor Diary
Detailed description:
Proof-of-concept phase 2a, double-blind, randomized, placebo-controlled, crossover study.
Eligibility
Minimum age: 30 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Chicago, Illinois 60612, United States
Toronto, Ontario M5T 2S8, Canada
Portland, Oregon 97239, United States
Additional Information
Starting date: July 2013
Last updated: June 22, 2015
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