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Comparison of IPX054, Immediate-Release Carbidopa-Levodopa, and Controlled-Release Carbidopa-Levodopa in Subjects With Parkinson's Disease

This study has been completed.
Information provided by:
IMPAX Laboratories, Inc. Identifier:
First received: January 18, 2006
Last updated: March 13, 2009
Last verified: March 2009
The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic Parkinson's disease.

Condition Intervention Phase
Idiopathic Parkinson's Disease
Drug: IPX054
Drug: Carbidopa-levodopa immediate-release tablets
Drug: CD-LD IR
Drug: CD-LD ER
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, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to Carbidopa-Levodopa Immediate-Release 200 (2x100) mg Tablets and Carbidopa-Levodopa Controlled-Release 200 mg Tablet in Subjects With Parkinson's Disease

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Alternate tapping of keys [ Time Frame: single dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Timed walking [ Time Frame: single dose ] [ Designated as safety issue: No ]
  • Tremor score [ Time Frame: single dose ] [ Designated as safety issue: No ]
  • Dyskinesia rating scale [ Time Frame: single dose ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: January 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
IPX054 200 mg
Drug: IPX054
IPX054 200 mg
Experimental: 2
IPX054 250 mg
Drug: Carbidopa-levodopa immediate-release tablets
IPX054 250 mg
Active Comparator: 3
Drug: CD-LD IR
200 mg
Active Comparator: 4
Drug: CD-LD ER
200 mg


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with idiopathic Parkinson's disease.
  • Currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
  • Must experience "wearing OFF" between doses of medication.

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 seizures.
  • Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.
  • Treatment with any dopaminergic blocking agent within the previous 3 months.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00279825

United States, Michigan
Quest Research Institute
Bingham Farms, Michigan, United States, 48025
United States, Oregon
Oregon Health Sciences University - Parkinson's Center of Oregon
Portland, Oregon, United States, 97239
Sponsors and Collaborators
IMPAX Laboratories, Inc.
  More Information

Responsible Party: Jeff Mulchahey, PhD/Sr. Director RA, IMPAX Laboratories Identifier: NCT00279825     History of Changes
Other Study ID Numbers: IPX054-B05-01 
Study First Received: January 18, 2006
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 drug combination
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors processed this record on January 18, 2017