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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00253084
First Posted: November 15, 2005
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
  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: IPX054 200 mg Drug: CD-LD IR Drug: IPX054 Placebo Drug: CD-LD IR Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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:


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

Primary Outcome Measures:
  • "ON" time without disabling dyskinesias [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • UPDRS analysis [ Time Frame: 2 weeks ]
  • Mean time to "ON" [ Time Frame: 2 weeks ]
  • Mean time to "wearing OFF" [ Time Frame: 2 weeks ]

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
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.
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
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.
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

Detailed Description:

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253084


Locations
United States, Illinois
Site 1
Chicago, Illinois, United States, 60612
United States, South Carolina
Site 2
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
IMPAX Laboratories, Inc.
Investigators
Study Director: Impax Impax Pharmaceuticals, a division of Impax Laboratories
  More Information

Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00253084     History of Changes
Other Study ID Numbers: IPX054-B04-07
First Submitted: November 11, 2005
First Posted: November 15, 2005
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists


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