DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Avanir Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyskinesia; Parkinson's Disease

Intervention: AVP-923-45 (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Avanir Pharmaceuticals

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Unified Dyskinesia Rating Scale (UDysRS), part 3

Secondary outcome:

UDysRS, part 4

Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III-motor score

Bradykinesia

MDS-UPDRS part I, II, and IV

UDysRS part 1 and 2

PD Motor Diary

Detailed description: Proof-of-concept phase 2a, double-blind, randomized, placebo-controlled, crossover study.

Eligibility

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Chicago, Illinois 60612, United States

Toronto, Ontario M5T 2S8, Canada

Portland, Oregon 97239, United States

Additional Information

Starting date: July 2013
Last updated: June 22, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017