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

Phase 1

Completed

• Conditions: Idiopathic Parkinson's Disease
• Interventions: Drug: IPX054 100 mg; Drug: IPX054 150 mg; Drug: IPX054 200 mg; Drug: IPX054 250 mg; Drug: IPX054 300 mg

• Registration Number: NCT00239564
• Lead Sponsor: Impax Laboratories, LLC

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-17
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2017-01
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: carbidopa and levodopa	IPX054 100 mg	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.
Experimental: carbidopa and levodopa	IPX054 150 mg	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.
Experimental: carbidopa and levodopa	IPX054 200 mg	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.
Experimental: carbidopa and levodopa	IPX054 250 mg	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.
Experimental: carbidopa and levodopa	IPX054 300 mg	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.

Primary Outcome Measures

Name	Time	Method
Parkinsonian disability at Visits 1 and 5	36 Days

Trial Locations

Locations (2)

Site 102; 🇺🇸 Lawrence, Kansas, United States

Site 101; 🇺🇸 Sunnyvale, California, United States