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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Avanir Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Parkinson's Disease
Dyskinesia

Treatments

Drug: Placebo
Drug: AVP-923-45

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01767129
12-AVR-133

Details and patient eligibility

About

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).

Full description

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

Enrollment

14 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

14 participants in 2 patient groups, including a placebo group

AVP-923-45
Experimental group
Description:
AVP-923-45 twice daily for 14 days
Treatment:
Drug: AVP-923-45
Placebo
Placebo Comparator group
Description:
Placebo twice a day for 14 days
Treatment:
Drug: Placebo

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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