Parkinson's Disease
Conditions
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.
Interventions
DRUGXP21279 and carbidopa (experimental)
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa
DRUGSinemet (comparator)
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet.
DRUGPlacebo 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
DRUGPlacebo for Sinemet
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet
Sponsors
XenoPort, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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®.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in mean daily off time at end of double-blind maintenance treatment periods. | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 2 weeks |
Countries
United States
Outcome results
None listed