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

This study has been completed.
Sponsor:
Information provided by:
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00869791
First received: March 24, 2009
Last updated: October 29, 2010
Last verified: October 2010
History of Changes
  Purpose

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
Endpoint Classification: Pharmacokinetics/Dynamics Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety (electrocardiogram, clinical laboratory tests, vital signs, AEs) and Pharmacodynamics (finger tapping, walking, UPDRS) [ Time Frame: 2x 1 Week ] [ Designated as safety issue: No ]

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
IPX066
 Drug: IPX066
IPX066
Other Name: CD-LD ER
Active Comparator: 2
CD-LD
 Drug: CD-LD
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869791

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

No publications provided by IMPAX Laboratories, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jeff Mulchahey, PhD/Sr. Director Regulatory Affairs, IMPAX Laboratories
ClinicalTrials.gov Identifier: NCT00869791     History of Changes
Other Study ID Numbers: IPX066-B08-11
Study First Received: March 24, 2009
Last Updated: October 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by IMPAX Laboratories, Inc.:
Parkinson's

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
Carbidopa, levodopa drug combination
Antiparkinson Agents
 Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on June 18, 2013