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

February 16, 2021 updated by: XenoPort, Inc.

A Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • XenoPort Clinical Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • XenoPort Clinical Site
    • California
      • Long Beach, California, United States, 90806
        • XenoPort Clinical Site
      • Sunnyvale, California, United States, 94085
        • XenoPort Clinical Site
    • Florida
      • Naples, Florida, United States, 34102
        • XenoPort Clinical Site
      • Tampa, Florida, United States, 33606
        • XenoPort Clinical Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • XenoPort Clinical Site
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • XenoPort Clinical Site
      • West Bloomfield, Michigan, United States, 48322-3013
        • XenoPort Clinical Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • XenoPort Clinical Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • XenoPort Clinical Site
    • Texas
      • Houston, Texas, United States, 77030
        • XenoPort Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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®.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods.
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome 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
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
XenoPort, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dan Chen, M.D., XenoPort, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XP-C-069
  • XenoPort (Other Identifier: XenoPort)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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