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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 20, 2014