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Completed

NCT Number: NCT00279825

Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease

The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic Parkinson's disease.

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Key information

Conditions

IDIOPATHIC PARKINSON'S DISEASE Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Quest Research Institute, Bingham Farms, Michigan, United States

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About this study

IPX054 contains two different drugs called levodopa and carbidopa in one tablet.

  • levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
  • carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with idiopathic Parkinson's disease.
  • Currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
  • Must experience "wearing OFF" between doses of medication.

Exclusion criteria

  • Diagnosed with atypical parkinsonism.
  • Allergic or non-responsive to previous carbidopa-levodopa therapy.
  • Active or history of narrow-angle or wide-angle glaucoma.
  • History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizures.
  • Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.
  • Treatment with any dopaminergic blocking agent within the previous 3 months.

Treatment and study plan

IPX054 200 mg

Drug

IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa

IPX054 250 mg

Drug

IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa

CD-LD IR

Drug

Active comparator containing 25 mg carbidopa and 100 mg levodopa

Other names: Carbidopa-levodopa immediate-release tablets

CD-LD CR

Drug

Active comparator containing 50 mg carbidopa and 200 mg levodopa

Other names: Carbidopa-levodopa controlled-release tablets

IPX054 200 mg Placebo

Drug

Placebo to match IPX054 200 mg

IPX054 250 mg Placebo

Drug

Placebo to match IPX054 250 mg

CD-LD IR Placebo

Drug

Placebo to match CD-LD IR

CD-LD CR Placebo

Drug

Placebo to match CD-LD CR

Primary outcomes

  1. Alternate tapping of keys

    Time frame: single dose

Secondary outcomes

  1. Timed walking

    Time frame: single dose

  2. Tremor score

    Time frame: single dose

  3. Dyskinesia rating scale

    Time frame: single dose

Sponsors and collaborators

Lead sponsor

Impax Laboratories, LLC

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet in Subjects With Parkinson's Disease

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 20, 2006
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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