Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00239564
First received: October 13, 2005
Last updated: March 13, 2009
Last verified: March 2009
  Purpose

The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release tablets.


Condition Intervention Phase
Idiopathic Parkinson's Disease
Drug: CD-LD ER
Drug: CD-LD IR
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by IMPAX Laboratories, Inc.:

Primary Outcome Measures:
  • Parkinsonian disability at Visits 1 and 5 [ Time Frame: 36 Days ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: October 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CD-LD ER
Drug: CD-LD ER
flexible dose
Other Name: IPX054
Active Comparator: 2
CD-LD IR
Drug: CD-LD IR
flexible dose
Other Name: Sinemet

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of idiopathic Parkinson's disease
  • Currently being treated with a stable dosage regimen of immediate-release carbidopa-levodopa for at least 3 months.
  • Must experience at least 3 episodes of "wearing OFF" symptoms and an average of at least 2 hours of "OFF" time per day.

Exclusion Criteria:

  • Diagnosed with atypical parkinsonism
  • Prior surgical interventions for Parkinson's disease
  • Glaucoma
  • Undiagnosed skin lesion or history of melanoma
  • Epilepsy or history of seizures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239564

Locations
United States, California
The Parkinson's Institute
Sunnyvale, California, United States, 94089
Sponsors and Collaborators
IMPAX Laboratories, Inc.
Investigators
Principal Investigator: James W. Tetrud, MD The Parkinson's Institute
  More Information

No publications provided

Responsible Party: Jeff Mulchahey, PhD/Sr. Director RA, IMPAX Laboratories
ClinicalTrials.gov Identifier: NCT00239564     History of Changes
Other Study ID Numbers: IPX054-B04-06
Study First Received: October 13, 2005
Last Updated: March 13, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by IMPAX Laboratories, Inc.:
IPX054
Parkinson disease
Levodopa

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 17, 2014