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

Tracking Information
First Received Date ^ICMJE	November 11, 2005
Last Updated Date	March 13, 2009
Start Date ^ICMJE	November 2005
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 13, 2009)	"ON" time without disabling dyskinesias [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: November 11, 2005)	"ON" time without disabling dyskinesias
Change History	Complete list of historical versions of study NCT00253084 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 13, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: November 11, 2005)	UPDRS analysis Mean time to "ON" Mean time to "wearing OFF"

Descriptive Information
Brief Title ^ICMJE	Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease
Official Title ^ICMJE	A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease
Brief Summary	The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release carbidopa-levodopa in subjects with Parkinson's disease.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Condition ^ICMJE	Parkinson's Disease
Intervention ^ICMJE	Drug: CD-LD ER Drug: Carbidopa-Levodopa
Study Arms / Comparison Groups	Experimental: IPX054 Active Comparator: CD-LD
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date	December 2007
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	30 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00253084
Responsible Party	Jeff Mulchahey, PhD/Sr. Director RA, IMPAX Laboratories
Study ID Numbers ^ICMJE	IPX054-B04-07
Study Sponsor ^ICMJE	IMPAX Laboratories, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
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