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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Avanir Pharmaceuticals
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01767129
First received: January 9, 2013
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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
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 ]

Estimated Enrollment: 16
Study Start Date: July 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01767129

Contacts
Contact: Sonal Patel 949-389-6791 spatel@avanir.com

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

No publications provided

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01767129     History of Changes
Other Study ID Numbers: 12-AVR-133
Study First Received: January 9, 2013
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Avanir Pharmaceuticals:
levodopa
dyskinesia
parkinson's disease
AVP-923
dextromethorphan
quinidine

Additional relevant MeSH terms:
Dyskinesias
Parkinson Disease
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases
Dextromethorphan
Levodopa
Quinidine
Quinidine gluconate
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Respiratory System Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 10, 2014