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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01767129
Recruitment Status : Completed
First Posted : January 14, 2013
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Dyskinesia Parkinson's Disease Drug: AVP-923-45 Drug: Placebo Phase 2

Detailed Description:
Proof-of-concept phase 2a, double-blind, randomized, placebo-controlled, crossover study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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.
Study Start Date : July 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : April 2015

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Unified Dyskinesia Rating Scale (UDysRS), part 3 [ Time Frame: 2 weeks ]

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

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767129


Locations
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01767129    
Other Study ID Numbers: 12-AVR-133
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Keywords provided by Avanir Pharmaceuticals:
levodopa
dyskinesia
parkinson's disease
 AVP-923
dextromethorphan
quinidine
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Excitatory Amino Acid Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Muscarinic Antagonists
Cholinergic Antagonists
Dyskinesias
Neurologic Manifestations
 Quinidine
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agents
Anti-Arrhythmia Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors