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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00253084
First received: November 11, 2005
Last updated: January 31, 2017
Last verified: January 2017
November 11, 2005
January 31, 2017
November 2005
December 2007   (Final data collection date for primary outcome measure)
"ON" time without disabling dyskinesias [ Time Frame: 2 weeks ]
"ON" time without disabling dyskinesias
Complete list of historical versions of study NCT00253084 on ClinicalTrials.gov Archive Site
  • UPDRS analysis [ Time Frame: 2 weeks ]
  • Mean time to "ON" [ Time Frame: 2 weeks ]
  • Mean time to "wearing OFF" [ Time Frame: 2 weeks ]
  • 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.

IPX054 contains two different drugs called levodopa and carbidopa in one tablet.

  • levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
  • carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: IPX054 200 mg
    IPX054 containing 50 mg carbidopa and 200 mg levodopa
    Other Name: CD-LD ER 200 mg
  • Drug: CD-LD IR
    CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
  • Drug: IPX054 Placebo
    Placebo to match IPX054 200 mg
  • Drug: CD-LD IR Placebo
    Placebo to match CD-LD IR
  • IPX054 - CD-LD IR
    Subjects received IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks and then received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks.
    Interventions:
    • Drug: IPX054 200 mg
    • Drug: CD-LD IR
    • Drug: IPX054 Placebo
    • Drug: CD-LD IR Placebo
  • CD-LD IR - IPX054
    Subjects received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks and then IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks.
    Interventions:
    • Drug: IPX054 200 mg
    • Drug: CD-LD IR
    • Drug: IPX054 Placebo
    • Drug: CD-LD IR Placebo
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.
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00253084
IPX054-B04-07
No
Not Provided
Plan to Share IPD: No
IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc.
Not Provided
Study Director: Impax Impax Pharmaceuticals, a division of Impax Laboratories
IMPAX Laboratories, Inc.
January 2017

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