A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects
This study has been completed.
Sponsor:
XenoPort, Inc.
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
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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:
MedlinePlus related topics:
Parkinson's Disease
Drug Information available for:
Carbidopa
U.S. FDA Resources
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:
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
Exclusion Criteria:
- 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®.
Contacts and Locations
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 Dopamine Agonists Adjuvants, Immunologic Immunologic Factors |
ClinicalTrials.gov processed this record on June 18, 2013