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An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects

This study has been completed.
Sponsor:
Information provided by:
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT00914602
First received: June 3, 2009
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

The purpose of the study is to assess the pharmacokinetics (PK), pharmacodynamics, and safety of XP21279 sustained release (SR3) formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease with Motor Fluctuations.


Condition Intervention Phase
Parkinson's Disease
Drug: XP21279
Drug: Sinemet®
Drug: Lodosyn®
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory Pharmacokinetic, Pharmacodynamic and Safety Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations

Resource links provided by NLM:


Further study details as provided by XenoPort, Inc.:

Primary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamic parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: May 2009
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm (Treatment Period A and B)

Treatment Period A: Sinemet® 25-100 treatment

Treatment Period B: Multiple-Dose XP21279 (with Lodosyn®) treatment

Drug: XP21279
After screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days. Upon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®).
Drug: Sinemet®
After screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days. Upon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®).
Drug: Lodosyn®
After screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days. Upon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®).

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects with a clinical diagnosis of idiopathic Parkinson's disease, confirmed by the presence of at least two cardinal signs of the disease (resting tremor, bradykinesia, rigidity).
  2. Subjects must have predictable motor fluctuations of the wearing off type, defined by wearing off in at least 50% of inter-dose intervals between the first and the last daily doses as recorded on the on/off diary over 3 days (Days -4 to -2) in the Screening Period.
  3. Subjects must be on stable TID or QID Sinemet® or carbidopa/levodopa regimens from morning through early evening, with a total daily dose ranging from 400 mg to 1000 mg of levodopa, for at least 1 week prior to Screening.

Exclusion Criteria:

  1. History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.
  2. Subject has greater than or equal to moderately disabling dyskinesias for greater than 25% of the waking day as assessed by a score of 2 or more on item 32 and a score of 2 or more on item 33 on the UPDRS at Screening.
  3. Subjects who are dosing with Sinemet® or carbidopa/levodopa during the night time.
  4. Subjects who have significant neurological symptoms not accounted for by Parkinson's disease.
  5. Subjects who are taking concomitantly COMT inhibitors (i.e., entacapone or tolcapone) or treated with Stalevo®, Sinemet® CR, or Madopar®/Prolopa® (levodopa/benserazide).
  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: NCT00914602

Locations
United States, Arizona
XenoPort Investigational Site
Peoria, Arizona, United States, 85381
United States, Michigan
XenoPort Investigational Site
Bingham Farms, Michigan, United States, 48025
Sponsors and Collaborators
XenoPort, Inc.
  More Information

No publications provided

Responsible Party: Dan Chen, M.D. Ph.D., Medical Director, XenoPort, Inc.
ClinicalTrials.gov Identifier: NCT00914602     History of Changes
Other Study ID Numbers: XP-C-058
Study First Received: June 3, 2009
Last Updated: May 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Carbidopa
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014