A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT01171313
First received: July 26, 2010
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after administration of XP21279/Carbidopa and Sinemet and to explore exposure-response relationships in a subset of subjects.


Condition Intervention Phase
Parkinson's Disease
Drug: XP21279 and carbidopa (experimental)
Drug: Sinemet (comparator)
Drug: Placebo for XP21279 and carbidopa
Drug: Placebo for Sinemet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 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:
  • Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of responders ("much improved" or "very much improved") on Investigator-rated and patient-rated CGI-I at end of double-blind Maintenance Treatment periods [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment sequence 1
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Drug: XP21279 and carbidopa (experimental)
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa
Drug: Sinemet (comparator)
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet.
Drug: Placebo for XP21279 and carbidopa
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for XP21279 and carbidopa
Drug: Placebo for Sinemet
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet
Experimental: Treatment sequence 2
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Drug: XP21279 and carbidopa (experimental)
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa
Drug: Sinemet (comparator)
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet.
Drug: Placebo for XP21279 and carbidopa
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for XP21279 and carbidopa
Drug: Placebo for Sinemet
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet
Experimental: Treatment sequence 3
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Drug: XP21279 and carbidopa (experimental)
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa
Drug: Sinemet (comparator)
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet.
Drug: Placebo for XP21279 and carbidopa
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for XP21279 and carbidopa
Drug: Placebo for Sinemet
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet
Experimental: Treatment sequence 4
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Drug: XP21279 and carbidopa (experimental)
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa
Drug: Sinemet (comparator)
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet.
Drug: Placebo for XP21279 and carbidopa
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for XP21279 and carbidopa
Drug: Placebo for Sinemet
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have predictable motor fluctuations of the wearing off type, defined by meeting the following criteria based on the on/off diaries recorded over 3 days in the Screening Period:

    • Wearing-off in at least half (50%) of inter-dose intervals between the first and the last daily doses averaged over the 3 diary days, and
    • An average daily "off" time of 2 hours after the first "on" of the day through awake time up to midnight.
  2. Subjects must be on one of the following stable QID or 5 times daily regimens for at least 4 weeks prior to Screening: Sinemet® or carbidopa-levodopa, with a total daily dose ranging from 400 mg to 1000 mg of levodopa

Exclusion Criteria:

  1. History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.
  2. Subject has moderately or severely disabling dyskinesias for greater than 25% of the waking day
  3. Subjects who have significant neurological symptoms not accounted for by Parkinson's disease
  4. Subjects who are taking Sinemet® CR, Parcopa®, concomitant COMT inhibitors (i.e., entacapone or tolcapone), Stalevo®, or benserazide containing levodopa preparations Madopar® or Prolopa®.
  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: NCT01171313

Locations
United States, Arizona
XenoPort Clinical Site
Phoenix, Arizona, United States, 85013
United States, Arkansas
XenoPort Clinical Site
Little Rock, Arkansas, United States, 72205
United States, California
XenoPort Clinical Site
Long Beach, California, United States, 90806
XenoPort Clinical Site
Sunnyvale, California, United States, 94085
United States, Florida
XenoPort Clinical Site
Naples, Florida, United States, 34102
XenoPort Clinical Site
Tampa, Florida, United States, 33606
United States, Kansas
XenoPort Clinical Site
Kansas City, Kansas, United States, 66160
United States, Michigan
XenoPort Clinical Site
Bingham Farms, Michigan, United States, 48025
XenoPort Clinical Site
West Bloomfield, Michigan, United States, 48322-3013
United States, New Jersey
XenoPort Clinical Site
New Brunswick, New Jersey, United States, 08901
United States, Oklahoma
XenoPort Clinical Site
Tulsa, Oklahoma, United States, 74137
United States, Texas
XenoPort Clinical Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
XenoPort, Inc.
Investigators
Study Director: Dan Chen, M.D. XenoPort, Inc.
  More Information

No publications provided

Responsible Party: XenoPort, Inc.
ClinicalTrials.gov Identifier: NCT01171313     History of Changes
Other Study ID Numbers: XP-C-069, XenoPort
Study First Received: July 26, 2010
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

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
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
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists

ClinicalTrials.gov processed this record on August 28, 2014