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Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00279825
First received: January 18, 2006
Last updated: January 31, 2017
Last verified: January 2017
  Purpose
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 200 mg
Drug: IPX054 250 mg
Drug: CD-LD IR
Drug: CD-LD CR
Drug: IPX054 200 mg Placebo
Drug: IPX054 250 mg Placebo
Drug: CD-LD IR Placebo
Drug: CD-LD CR Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, 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 CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 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 ]

Secondary Outcome Measures:
  • Timed walking [ Time Frame: single dose ]
  • Tremor score [ Time Frame: single dose ]
  • Dyskinesia rating scale [ Time Frame: single dose ]

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
Sequence 1
Subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR.
Drug: IPX054 200 mg
IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa
Drug: IPX054 250 mg
IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa
Drug: CD-LD IR
Active comparator containing 25 mg carbidopa and 100 mg levodopa
Other Name: Carbidopa-levodopa immediate-release tablets
Drug: CD-LD CR
Active comparator containing 50 mg carbidopa and 200 mg levodopa
Other Name: Carbidopa-levodopa controlled-release tablets
Drug: IPX054 200 mg Placebo
Placebo to match IPX054 200 mg
Drug: IPX054 250 mg Placebo
Placebo to match IPX054 250 mg
Drug: CD-LD IR Placebo
Placebo to match CD-LD IR
Drug: CD-LD CR Placebo
Placebo to match CD-LD CR
Sequence 2
Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo.
Drug: IPX054 200 mg
IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa
Drug: IPX054 250 mg
IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa
Drug: CD-LD IR
Active comparator containing 25 mg carbidopa and 100 mg levodopa
Other Name: Carbidopa-levodopa immediate-release tablets
Drug: CD-LD CR
Active comparator containing 50 mg carbidopa and 200 mg levodopa
Other Name: Carbidopa-levodopa controlled-release tablets
Drug: IPX054 200 mg Placebo
Placebo to match IPX054 200 mg
Drug: IPX054 250 mg Placebo
Placebo to match IPX054 250 mg
Drug: CD-LD IR Placebo
Placebo to match CD-LD IR
Drug: CD-LD CR Placebo
Placebo to match CD-LD CR
Sequence 3
Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Third treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo.
Drug: IPX054 200 mg
IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa
Drug: IPX054 250 mg
IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa
Drug: CD-LD IR
Active comparator containing 25 mg carbidopa and 100 mg levodopa
Other Name: Carbidopa-levodopa immediate-release tablets
Drug: CD-LD CR
Active comparator containing 50 mg carbidopa and 200 mg levodopa
Other Name: Carbidopa-levodopa controlled-release tablets
Drug: IPX054 200 mg Placebo
Placebo to match IPX054 200 mg
Drug: IPX054 250 mg Placebo
Placebo to match IPX054 250 mg
Drug: CD-LD IR Placebo
Placebo to match CD-LD IR
Drug: CD-LD CR Placebo
Placebo to match CD-LD CR
Sequence 4
Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo.
Drug: IPX054 200 mg
IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa
Drug: IPX054 250 mg
IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa
Drug: CD-LD IR
Active comparator containing 25 mg carbidopa and 100 mg levodopa
Other Name: Carbidopa-levodopa immediate-release tablets
Drug: CD-LD CR
Active comparator containing 50 mg carbidopa and 200 mg levodopa
Other Name: Carbidopa-levodopa controlled-release tablets
Drug: IPX054 200 mg Placebo
Placebo to match IPX054 200 mg
Drug: IPX054 250 mg Placebo
Placebo to match IPX054 250 mg
Drug: CD-LD IR Placebo
Placebo to match CD-LD IR
Drug: CD-LD CR Placebo
Placebo to match CD-LD CR

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

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.
  • 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
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: NCT00279825

Locations
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.
Investigators
Study Director: Impax Impax Pharmaceuticals, a division of Impax Laboratories
  More Information

Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00279825     History of Changes
Other Study ID Numbers: IPX054-B05-01 
Study First Received: January 18, 2006
Last Updated: January 31, 2017
Individual Participant Data  
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
Carbidopa, levodopa drug combination
Carbidopa
Levodopa
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

ClinicalTrials.gov processed this record on February 20, 2017