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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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 ]

Secondary Outcome Measures:
  • UDysRS, part 4 [ Time Frame: 2 Weeks ]
  • Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III-motor score [ Time Frame: 2 Weeks ]
  • Bradykinesia [ Time Frame: 2 Weeks ]
  • MDS-UPDRS part I, II, and IV [ Time Frame: 2 Weeks ]
  • UDysRS part 1 and 2 [ Time Frame: 2 Weeks ]
  • PD Motor Diary [ Time Frame: 2 Weeks ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Avanir Pharmaceuticals:
parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Quinidine gluconate
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antimalarials processed this record on September 19, 2017