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A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
XP21279 and carbidopa (experimental)
Sinemet (comparator)
Placebo for XP21279 and carbidopa
Placebo for Sinemet
Sponsored by
XenoPort, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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®.

Sites / Locations

  • XenoPort Clinical Site
  • XenoPort Clinical Site
  • XenoPort Clinical Site
  • XenoPort Clinical Site
  • XenoPort Clinical Site
  • XenoPort Clinical Site
  • XenoPort Clinical Site
  • XenoPort Clinical Site
  • XenoPort Clinical Site
  • XenoPort Clinical Site
  • XenoPort Clinical Site
  • XenoPort Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment sequence 1

Treatment sequence 2

Treatment sequence 3

Treatment sequence 4

Arm Description

Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.

Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.

Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.

Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.

Outcomes

Primary Outcome Measures

Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods.

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

Full Information

First Posted
July 26, 2010
Last Updated
February 16, 2021
Sponsor
XenoPort, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01171313
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XenoPort, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment sequence 1
Arm Type
Experimental
Arm Description
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Arm Title
Treatment sequence 2
Arm Type
Experimental
Arm Description
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Arm Title
Treatment sequence 3
Arm Type
Experimental
Arm Description
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Arm Title
Treatment sequence 4
Arm Type
Experimental
Arm Description
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
Intervention Type
Drug
Intervention Name(s)
XP21279 and carbidopa (experimental)
Intervention Description
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa
Intervention Type
Drug
Intervention Name(s)
Sinemet (comparator)
Intervention Description
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet.
Intervention Type
Drug
Intervention Name(s)
Placebo for XP21279 and carbidopa
Intervention Description
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for XP21279 and carbidopa
Intervention Type
Drug
Intervention Name(s)
Placebo for Sinemet
Intervention Description
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet
Primary Outcome Measure Information:
Title
Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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®.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Chen, M.D.
Organizational Affiliation
XenoPort, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
XenoPort Clinical Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
XenoPort Clinical Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
XenoPort Clinical Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
XenoPort Clinical Site
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94085
Country
United States
Facility Name
XenoPort Clinical Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
XenoPort Clinical Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
XenoPort Clinical Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
XenoPort Clinical Site
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
XenoPort Clinical Site
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322-3013
Country
United States
Facility Name
XenoPort Clinical Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
XenoPort Clinical Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74137
Country
United States
Facility Name
XenoPort Clinical Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects

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