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

This study has been completed.
Sponsor:
Information provided by:
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00253084
First received: November 11, 2005
Last updated: March 13, 2009
Last verified: March 2009

November 11, 2005
March 13, 2009
November 2005
December 2007   (final data collection date for primary outcome measure)
"ON" time without disabling dyskinesias [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
"ON" time without disabling dyskinesias
Complete list of historical versions of study NCT00253084 on ClinicalTrials.gov Archive Site
  • 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 ]
  • UPDRS analysis
  • Mean time to "ON"
  • Mean time to "wearing OFF"
Not Provided
Not Provided
 
Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease
A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: CD-LD ER
    b.i.d.
    Other Name: IPX054
  • Drug: Carbidopa-Levodopa
    q.i.d.
    Other Name: Sinemet
  • Experimental: 1
    IPX054
    Intervention: Drug: CD-LD ER
  • Active Comparator: 2
    CD-LD
    Intervention: Drug: Carbidopa-Levodopa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00253084
IPX054-B04-07
No
Jeff Mulchahey, PhD/Sr. Director RA, IMPAX Laboratories
IMPAX Laboratories, Inc.
Not Provided
Not Provided
IMPAX Laboratories, Inc.
March 2009

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