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

This study has been completed.

Sponsor:

Information provided by:

IMPAX Laboratories, Inc.

ClinicalTrials.gov Identifier:

NCT00239564

First received: October 13, 2005

Last updated: March 13, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 13, 2005

Last Updated Date

March 13, 2009

Start Date ^ICMJE

October 2005

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Parkinsonian disability at Visits 1 and 5 [ Time Frame: 36 Days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Parkinsonian disability at Visits 1 and 5

Change History

Complete list of historical versions of study NCT00239564 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Idiopathic Parkinson's Disease

Intervention ^ICMJE

Drug: CD-LD ER
flexible dose

Other Name: IPX054
Drug: CD-LD IR
flexible dose

Other Name: Sinemet

Study Arm (s)

Experimental: 1
CD-LD ER

Intervention: Drug: CD-LD ER
Active Comparator: 2
CD-LD IR

Intervention: Drug: CD-LD IR

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00239564

Other Study ID Numbers ^ICMJE

IPX054-B04-06

Has Data Monitoring Committee

Responsible Party

Jeff Mulchahey, PhD/Sr. Director RA, IMPAX Laboratories

Study Sponsor ^ICMJE

IMPAX Laboratories, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

James W. Tetrud, MD

The Parkinson's Institute

Information Provided By

IMPAX Laboratories, Inc.

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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