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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:
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00253084
First received: November 11, 2005
Last updated: March 13, 2009
Last verified: March 2009
History of Changes
  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 2

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, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease

Resource links provided by NLM:

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
Experimental: 1
IPX054
 Drug: CD-LD ER
b.i.d.
Other Name: IPX054
Active Comparator: 2
CD-LD
 Drug: Carbidopa-Levodopa
q.i.d.
Other Name: Sinemet

  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: Jeff Mulchahey, PhD/Sr. Director RA, IMPAX Laboratories
ClinicalTrials.gov Identifier: NCT00253084     History of Changes
Other Study ID Numbers: IPX054-B04-07
Study First Received: November 11, 2005
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 May 19, 2013