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
2 other identifiers
interventional
35
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2010
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 26, 2010
CompletedFirst Posted
Study publicly available on registry
July 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 18, 2021
February 1, 2021
1.3 years
July 26, 2010
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods.
2 weeks
Secondary Outcomes (1)
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
Study Arms (4)
Treatment sequence 1
EXPERIMENTALSubjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 2
EXPERIMENTALSubjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 3
EXPERIMENTALSubjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Treatment sequence 4
EXPERIMENTALSubjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Interventions
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet.
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed 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 Sinemet
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.
- Subject has moderately or severely disabling dyskinesias for greater than 25% of the waking day
- Subjects who have significant neurological symptoms not accounted for by Parkinson's disease
- Subjects who are taking Sinemet® CR, Parcopa®, concomitant COMT inhibitors (i.e., entacapone or tolcapone), Stalevo®, or benserazide containing levodopa preparations Madopar® or Prolopa®.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XenoPort, Inc.lead
Study Sites (12)
XenoPort Clinical Site
Phoenix, Arizona, 85013, United States
XenoPort Clinical Site
Little Rock, Arkansas, 72205, United States
XenoPort Clinical Site
Long Beach, California, 90806, United States
XenoPort Clinical Site
Sunnyvale, California, 94085, United States
XenoPort Clinical Site
Naples, Florida, 34102, United States
XenoPort Clinical Site
Tampa, Florida, 33606, United States
XenoPort Clinical Site
Kansas City, Kansas, 66160, United States
XenoPort Clinical Site
Bingham Farms, Michigan, 48025, United States
XenoPort Clinical Site
West Bloomfield, Michigan, 48322-3013, United States
XenoPort Clinical Site
New Brunswick, New Jersey, 08901, United States
XenoPort Clinical Site
Tulsa, Oklahoma, 74137, United States
XenoPort Clinical Site
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dan Chen, M.D.
XenoPort, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2010
First Posted
July 28, 2010
Study Start
July 1, 2010
Primary Completion
October 1, 2011
Study Completion
December 1, 2011
Last Updated
February 18, 2021
Record last verified: 2021-02