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Trial record 8 of 16 for:    glutamate antagonist | Parkinson Disease

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

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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

Tracking Information
First Submitted Date  ICMJE January 9, 2013
First Posted Date  ICMJE January 14, 2013
Last Update Posted Date January 11, 2018
Study Start Date  ICMJE July 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2013)
Unified Dyskinesia Rating Scale (UDysRS), part 3 [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01767129 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients
Official Title  ICMJE 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.
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).
Detailed Description Proof-of-concept phase 2a, double-blind, randomized, placebo-controlled, crossover study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dyskinesia
  • Parkinson's Disease
Intervention  ICMJE
  • Drug: AVP-923-45
    One capsule twice daily for 14 days
    Other Name: dextromethorphan/quinidine
  • Drug: Placebo
    One capsule twice daily for 14 days
Study Arms  ICMJE
  • Experimental: AVP-923-45
    AVP-923-45 twice daily for 14 days
    Intervention: Drug: AVP-923-45
  • Placebo Comparator: Placebo
    Placebo twice a day for 14 days
    Intervention: Drug: Placebo
Publications * Fox SH, Metman LV, Nutt JG, Brodsky M, Factor SA, Lang AE, Pope LE, Knowles N, Siffert J. Trial of dextromethorphan/quinidine to treat levodopa-induced dyskinesia in Parkinson's disease. Mov Disord. 2017 Jun;32(6):893-903. doi: 10.1002/mds.26976. Epub 2017 Mar 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2015)
14
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2013)
16
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01767129
Other Study ID Numbers  ICMJE 12-AVR-133
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avanir Pharmaceuticals
Study Sponsor  ICMJE Avanir Pharmaceuticals
Collaborators  ICMJE Michael J. Fox Foundation for Parkinson's Research
Investigators  ICMJE Not Provided
PRS Account Avanir Pharmaceuticals
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP