Trial | NCT00239564  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    carbidopa ...

  • Study Participants

    12
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.
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.
Study Started
Oct 31
2005
Primary Completion
Dec 31
2007
Study Completion
Dec 31
2007
Last Update
Oct 29
2019

Drug IPX054 100 mg

IPX054 containing 25 mg carbidopa and 100 mg levodopa

  • Other names: CD-LD ER 100 mg

Drug IPX054 150 mg

IPX054 containing 37.5 mg carbidopa and 150 mg levodopa

  • Other names: CD-LD ER 150 mg

Drug IPX054 200 mg

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

  • Other names: CD-LD ER 200 mg

Drug IPX054 250 mg

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

  • Other names: CD-LD ER 250 mg

Drug IPX054 300 mg

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

  • Other names: CD-LD ER 300 mg

Experimental: carbidopa and levodopa Experimental

Subjects receive IPX054 100 mg, IPX054 150 mg, IPX054 200 mg, IPX054 250 mg, or IPX054 300 mg to achieve optimum dosage and dosing frequency as directed by the Investigator for 5 weeks.

Criteria 

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
No Results Posted