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OpenTrials
Completed

NCT Number: NCT00239564

Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease

The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release tablets.

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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 1 / Phase 2

Primary location

Site 101, Sunnyvale, California, 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

  • Clinical diagnosis of idiopathic Parkinson's disease
  • Currently being treated with a stable dosage regimen of immediate-release carbidopa-levodopa for at least 3 months.
  • Must experience at least 3 episodes of "wearing OFF" symptoms and an average of at least 2 hours of "OFF" time per day.

Exclusion criteria

  • Diagnosed with atypical parkinsonism
  • Prior surgical interventions for Parkinson's disease
  • Glaucoma
  • Undiagnosed skin lesion or history of melanoma
  • Epilepsy or history of seizures

Treatment and study plan

IPX054 100 mg

Drug

IPX054 containing 25 mg carbidopa and 100 mg levodopa

Other names: CD-LD ER 100 mg

IPX054 150 mg

Drug

IPX054 containing 37.5 mg carbidopa and 150 mg levodopa

Other names: CD-LD ER 150 mg

IPX054 200 mg

Drug

CD-LD CR containing 50 mg carbidopa and 200 mg levodopa

Other names: CD-LD ER 200 mg

IPX054 250 mg

Drug

CD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa

Other names: CD-LD ER 250 mg

IPX054 300 mg

Drug

CD-LD CR containing 75 mg carbidopa and 300 mg levodopa

Other names: CD-LD ER 300 mg

Primary outcomes

  1. Parkinsonian disability at Visits 1 and 5

    Time frame: 36 Days

Sponsors and collaborators

Lead sponsor

Impax Laboratories, LLC

Industry

Registry information

Official study title

An Open-Label Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 17, 2005
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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