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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
History of Changes

July 26, 2010
February 4, 2013
July 2010
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01171313 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects
A Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • 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 1
    Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
    Interventions:
    • Drug: XP21279 and carbidopa (experimental)
    • Drug: Sinemet (comparator)
    • Drug: Placebo for XP21279 and carbidopa
    • Drug: 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.
    Interventions:
    • Drug: XP21279 and carbidopa (experimental)
    • Drug: Sinemet (comparator)
    • Drug: Placebo for XP21279 and carbidopa
    • Drug: 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.
    Interventions:
    • Drug: XP21279 and carbidopa (experimental)
    • Drug: Sinemet (comparator)
    • Drug: Placebo for XP21279 and carbidopa
    • Drug: 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.
    Interventions:
    • Drug: XP21279 and carbidopa (experimental)
    • Drug: Sinemet (comparator)
    • Drug: Placebo for XP21279 and carbidopa
    • Drug: Placebo for Sinemet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
December 2011
October 2011   (final data collection date for primary outcome measure)

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®.
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01171313
XP-C-069, XenoPort
No
XenoPort, Inc.
XenoPort, Inc.
Not Provided
Study Director: Dan Chen, M.D. XenoPort, Inc.
XenoPort, Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP