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

Idiopathic Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239564
• Other study ID #: IPX054-B04-06
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2005
• Est. completion date: December 2007

Study information

• Verified date: January 2017
• Source: Impax Laboratories, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• IPX054 100 mg
IPX054 containing 25 mg carbidopa and 100 mg levodopa
• IPX054 150 mg
IPX054 containing 37.5 mg carbidopa and 150 mg levodopa
• IPX054 200 mg
CD-LD CR containing 50 mg carbidopa and 200 mg levodopa
• IPX054 250 mg
CD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa
• IPX054 300 mg
CD-LD CR containing 75 mg carbidopa and 300 mg levodopa

Locations

Country	Name	City	State
United States	Site 102	Lawrence	Kansas
United States	Site 101	Sunnyvale	California

Sponsors (1)

Lead Sponsor	Collaborator
Impax Laboratories, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parkinsonian disability at Visits 1 and 5		36 Days