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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01767129
• Date of registration: 09/01/2013
• Prospective Registration: Yes
• Primary sponsor: Avanir Pharmaceuticals
• Public title: Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients LID in PD
• Scientific 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.
• Date of first enrolment: July 2013
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01767129
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Canada, United States

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Dyskinesia

Intervention(s)

Drug: AVP-923-45

Drug: Placebo

Primary Outcome(s)

Unified Dyskinesia Rating Scale (UDysRS), part 3 [Time Frame: 2 weeks]

Secondary Outcome(s)

Bradykinesia [Time Frame: 2 Weeks]

UDysRS part 1 and 2 [Time Frame: 2 Weeks]

UDysRS, part 4 [Time Frame: 2 Weeks]

PD Motor Diary [Time Frame: 2 Weeks]

MDS-UPDRS part I, II, and IV [Time Frame: 2 Weeks]

Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III-motor score [Time Frame: 2 Weeks]

Secondary ID(s)

12-AVR-133

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Michael J. Fox Foundation for Parkinson's Research