Comparison of IPX054, Immediate-Release Carbidopa-Levodopa, and Controlled-Release Carbidopa-Levodopa in Subjects With Parkinson's Disease - Full Text View

Sponsor:	IMPAX Laboratories, Inc.
Information provided by:	IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00279825

Purpose

The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic Parkinson's disease.

Condition	Intervention	Phase
Idiopathic Parkinson's Disease	Drug: IPX054 Drug: Carbidopa-levodopa immediate-release tablets Drug: CD-LD IR Drug: CD-LD ER	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to Carbidopa-Levodopa Immediate-Release 200 (2x100) mg Tablets and Carbidopa-Levodopa Controlled-Release 200 mg Tablet in Subjects With Parkinson's Disease

Resource links provided by NLM:

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

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:

Alternate tapping of keys [ Time Frame: single dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Timed walking [ Time Frame: single dose ] [ Designated as safety issue: No ]
Tremor score [ Time Frame: single dose ] [ Designated as safety issue: No ]
Dyskinesia rating scale [ Time Frame: single dose ] [ Designated as safety issue: No ]

Enrollment:	16
Study Start Date:	January 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 IPX054 200 mg	Drug: IPX054 IPX054 200 mg
Experimental: 2 IPX054 250 mg	Drug: Carbidopa-levodopa immediate-release tablets IPX054 250 mg
Active Comparator: 3 CD-LD IR	Drug: CD-LD IR 200 mg
Active Comparator: 4 CD-LD ER	Drug: CD-LD ER 200 mg

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.
Currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
Must experience "wearing OFF" between doses of medication.

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 seizures.
Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.
Treatment with any dopaminergic blocking agent within the previous 3 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279825

Locations

United States, Michigan
Quest Research Institute
Bingham Farms, Michigan, United States, 48025
United States, Oregon
Oregon Health Sciences University - Parkinson's Center of Oregon
Portland, Oregon, United States, 97239

Sponsors and Collaborators

IMPAX Laboratories, Inc.

More Information

No publications provided

Responsible Party:	Jeff Mulchahey, PhD/Sr. Director RA, IMPAX Laboratories
ClinicalTrials.gov Identifier:	NCT00279825 History of Changes
Other Study ID Numbers:	IPX054-B05-01
Study First Received:	January 18, 2006
Last Updated:	March 13, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
Carbidopa, levodopa drug combination
Antiparkinson Agents

Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on February 09, 2012