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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00914602
First Posted: June 5, 2009
Last Update Posted: May 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
XenoPort, Inc.
  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: None (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 ]

Secondary Outcome Measures:
  • Pharmacodynamic parameters [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 3, 2009
First Posted: June 5, 2009
Last Update Posted: May 20, 2011
Last Verified: May 2011

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