Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease

This study has been completed.

First Received: November 11, 2005 Last Updated: March 13, 2009 History of Changes

Sponsor:	IMPAX Laboratories, Inc.
Information provided by:	IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00253084

Purpose

The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release carbidopa-levodopa in subjects with Parkinson's disease.

Condition	Intervention	Phase
Parkinson's Disease	Drug: CD-LD ER Drug: Carbidopa-Levodopa	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Carbidopa Sinemet

U.S. FDA Resources

Further study details as provided by IMPAX Laboratories, Inc.:

Primary Outcome Measures:

"ON" time without disabling dyskinesias [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

UPDRS analysis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Mean time to "ON" [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Mean time to "wearing OFF" [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	November 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental IPX054	Drug: CD-LD ER b.i.d.
2: Active Comparator CD-LD	Drug: Carbidopa-Levodopa q.i.d.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed with idiopathic Parkinson's disease based on CAPIT (Core Assessment Program for Intracerebral Transplantations) criteria.
Currently being treated with immediate-release carbidopa-levodopa with a stable dosing regimen over the past 4 weeks.

Exclusion Criteria:

Diagnosed with atypical parkinsonism.
Allergic or non-responsive to previous carbidopa-levodopa therapy.
Active or history of narrow-angle or wide-angle glaucoma.
History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizure.
Requires concomitant therapy with tricyclic antidepressants, MAO-B inhibitors, COMT inhibitors or anticholinergics.
Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 6 months.
Treatment with any dopaminergic blocking agent within the previous 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253084

Locations

United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612

Sponsors and Collaborators

IMPAX Laboratories, Inc.

More Information

No publications provided

Responsible Party:	IMPAX Laboratories ( Jeff Mulchahey, PhD/Sr. Director RA )
Study ID Numbers:	IPX054-B04-07
Study First Received:	November 11, 2005
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00253084 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Agents
Levodopa
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Carbidopa
Adjuvants, Immunologic
Central Nervous System Diseases
Antiparkinson Agents

Enzyme Inhibitors
Dopamine Agonists
Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Sinemet
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009