Clinical trial NCT01171313: A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects
Official title: A Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: XenoPort, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-28
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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®.

Primary outcomes:
measure: Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods.
timeFrame: 2 weeks
Secondary outcomes:
measure: 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
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: XenoPort Clinical Site
state: Arizona
city: Little Rock
country: United States
facility: XenoPort Clinical Site
state: Arkansas
city: Long Beach
country: United States
facility: XenoPort Clinical Site
state: California
city: Sunnyvale
country: United States
facility: XenoPort Clinical Site
state: California
city: Naples
country: United States
facility: XenoPort Clinical Site
state: Florida
city: Tampa
country: United States
facility: XenoPort Clinical Site
state: Florida
city: Kansas City
country: United States
facility: XenoPort Clinical Site
state: Kansas
city: Bingham Farms
country: United States
facility: XenoPort Clinical Site
state: Michigan
city: West Bloomfield
country: United States
facility: XenoPort Clinical Site
state: Michigan
city: New Brunswick
country: United States
facility: XenoPort Clinical Site
state: New Jersey
city: Tulsa
country: United States
facility: XenoPort Clinical Site
state: Oklahoma
city: Houston
country: United States
facility: XenoPort Clinical Site
state: Texas
Study officials:
affiliation: XenoPort, Inc.
name: Dan Chen, M.D.
role: STUDY_DIRECTOR
References: