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

This study has been completed.
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Avanir Pharmaceuticals Identifier:
First received: January 9, 2013
Last updated: June 22, 2015
Last verified: June 2015
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).

Condition Intervention Phase
Parkinson's Disease
Drug: AVP-923-45
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:
  • Unified Dyskinesia Rating Scale (UDysRS), part 3 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • UDysRS, part 4 [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III-motor score [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
  • Bradykinesia [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • MDS-UPDRS part I, II, and IV [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
  • UDysRS part 1 and 2 [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • PD Motor Diary [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: July 2013
Study Completion Date: April 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AVP-923-45
AVP-923-45 twice daily for 14 days
Drug: AVP-923-45
One capsule twice daily for 14 days
Other Name: dextromethorphan/quinidine
Placebo Comparator: Placebo
Placebo twice a day for 14 days
Drug: Placebo
One capsule twice daily for 14 days

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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01767129

United States, Illinois
Chicago, Illinois, United States, 60612
United States, Oregon
Portland, Oregon, United States, 97239
Canada, Ontario
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
Avanir Pharmaceuticals
Michael J. Fox Foundation for Parkinson's Research
  More Information

Responsible Party: Avanir Pharmaceuticals Identifier: NCT01767129     History of Changes
Other Study ID Numbers: 12-AVR-133 
Study First Received: January 9, 2013
Last Updated: June 22, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Avanir Pharmaceuticals:
parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Parkinsonian Disorders
Signs and Symptoms
Quinidine gluconate
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Anti-Arrhythmia Agents
Anti-Dyskinesia Agents
Anti-Infective Agents
Antiparasitic Agents
Antiparkinson Agents
Antiprotozoal Agents
Antitussive Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists processed this record on April 27, 2016