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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-16

Study Completion Date

2015-02-05

Brief Summary

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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).

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Detailed Description

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

Conditions

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Dyskinesia Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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AVP-923-45

AVP-923-45 twice daily for 14 days

Group Type EXPERIMENTAL

AVP-923-45

Intervention Type DRUG

One capsule twice daily for 14 days

Placebo

Placebo twice a day for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One capsule twice daily for 14 days

Interventions

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AVP-923-45

One capsule twice daily for 14 days

Intervention Type DRUG

Placebo

One capsule twice daily for 14 days

Intervention Type DRUG

Other Intervention Names

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dextromethorphan/quinidine

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No