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A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa

This study has been completed.
Information provided by:
IMPAX Laboratories, Inc. Identifier:
First received: March 24, 2009
Last updated: October 29, 2010
Last verified: October 2010
This study compares the pharmacokinetics and effectiveness of IPX066 to standard cabridopa-levodopa

Condition Intervention Phase
Parkinson's Disease
Drug: IPX066
Drug: CD-LD
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Pharmacokinetics: CD and LD Cmax, Tmax, AUC, half-life [ Time Frame: 2x 1 week ]

Secondary Outcome Measures:
  • Safety (electrocardiogram, clinical laboratory tests, vital signs, AEs) and Pharmacodynamics (finger tapping, walking, UPDRS) [ Time Frame: 2x 1 Week ]

Enrollment: 27
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: IPX066
Other Name: CD-LD ER
Active Comparator: 2
Drug: CD-LD

Detailed Description:

This is a randomized, open-label, multicenter, 2 period, crossover study. Approximately 24 qualified LD experienced Parkinson's disease (PD) subjects are equally randomized to 1 of 2 dosing sequences.

During each treatment period subjects receive 7 days of medication. Pharmacokinetics and pharmacodynamic measures are assessed during each treatment period. Additionally, subject diaries are completed.


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

Inclusion Criteria:

  1. Male or female diagnosed with idiopathic PD, without any known cause for Parkinsonism.
  2. If female and of childbearing potential, subject should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier). The subject must agree to take every precaution to ensure that pregnancy will not occur during the study.
  3. At least 30 years old at the time of diagnosis of PD.
  4. Mini Mental State Examination (MMSE) ≥ 26 at Screening Visit.
  5. A responder to LD and currently being chronically treated with stable dosage of commercially available standard, orally disintegrating, or controlled-release CD LD for at least 1 month.
  6. Must have predictable fluctuations between "on" and "off" states.
  7. Hoehn and Yahr Stage I-IV when "on".
  8. Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
  9. Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections.

Exclusion Criteria:

  1. Pregnant or breastfeeding.
  2. Diagnosed with atypical parkinsonism.
  3. History, physical findings or laboratory results suggesting a diagnosis other than PD.
  4. Allergic or nonresponsive to previous CD-LD therapy.
  5. Any medical (e.g., liver or kidney impairment, peptic ulcer) or condition/history that, in the Investigator's opinion, may jeopardize the subject's safety.
  6. Exposure to any investigational agent within 30 days prior to Visit 1.
  7. Donated blood or plasma within 28 days.

20. Had prior functional neurosurgical treatment for PD (ablation or Deep Brain Stimulation).

  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 identifier: NCT00869791

United States, Michigan
IMPAX Laboratories site
Not specified, Michigan, United States, 99999
Sponsors and Collaborators
IMPAX Laboratories, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jeff Mulchahey, PhD/Sr. Director Regulatory Affairs, IMPAX Laboratories Identifier: NCT00869791     History of Changes
Other Study ID Numbers: IPX066-B08-11
Study First Received: March 24, 2009
Last Updated: October 29, 2010

Keywords provided by IMPAX Laboratories, Inc.:

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
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors processed this record on March 27, 2017