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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00239564
First received: October 13, 2005
Last updated: January 31, 2017
Last verified: January 2017
  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: IPX054 100 mg Drug: IPX054 150 mg Drug: IPX054 200 mg Drug: IPX054 250 mg Drug: IPX054 300 mg Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]

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: Experimental: carbidopa and levodopa
Subjects receive IPX054 100 mg, IPX054 150 mg, IPX054 200 mg, IPX054 250 mg, or IPX054 300 mg to achieve optimum dosage and dosing frequency as directed by the Investigator for 5 weeks.
Drug: IPX054 100 mg
IPX054 containing 25 mg carbidopa and 100 mg levodopa
Other Name: CD-LD ER 100 mg
Drug: IPX054 150 mg
IPX054 containing 37.5 mg carbidopa and 150 mg levodopa
Other Name: CD-LD ER 150 mg
Drug: IPX054 200 mg
CD-LD CR containing 50 mg carbidopa and 200 mg levodopa
Other Name: CD-LD ER 200 mg
Drug: IPX054 250 mg
CD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa
Other Name: CD-LD ER 250 mg
Drug: IPX054 300 mg
CD-LD CR containing 75 mg carbidopa and 300 mg levodopa
Other Name: CD-LD ER 300 mg

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:

  • 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
Site 101
Sunnyvale, California, United States, 94089
United States, Kansas
Site 102
Lawrence, Kansas, United States, 66045
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: NCT00239564     History of Changes
Other Study ID Numbers: IPX054-B04-06
Study First Received: October 13, 2005
Last Updated: January 31, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Levodopa
Carbidopa
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

ClinicalTrials.gov processed this record on September 21, 2017