Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis

February 17, 2021 updated by: XenoPort, Inc.

A Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis

To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo for the treatment of spasticity in subjects with multiple sclerosis (MS).

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.
228

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 3

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, 85004
        • XenoPort Clinical Site
      • Tucson, Arizona, United States, 85701
        • XenoPort Clinical Site
    • California
      • Berkeley, California, United States, 94705
        • XenoPort Clinical Site
      • San Diego, California, United States, 92103
        • XenoPort Clinical Site
    • Colorado
      • Denver, Colorado, United States, 80012
        • XenoPort Clinical Site
    • Florida
      • Port Charlotte, Florida, United States, 33948
        • XenoPort Clinical Site
      • Saint Petersburg, Florida, United States, 33701
        • XenoPort Clinical Site
      • Sarasota, Florida, United States, 34231
        • XenoPort Clinical Site
      • Tampa, Florida, United States, 33604
        • XenoPort Clinical Site
    • Illinois
      • Lake Barrington, Illinois, United States, 60010
        • XenoPort Clinical Site
    • Indiana
      • Indianapolis, Indiana, United States, 46204
        • XenoPort Clinical Site
    • Kansas
      • Lenexa, Kansas, United States, 66210
        • XenoPort Clinical Site
    • Kentucky
      • Lexington, Kentucky, United States, 40505
        • XenoPort Clinical Site
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • XenoPort Clinical Site
      • Detroit, Michigan, United States, 48202
        • XenoPort Clinical Site
    • New Jersey
      • Toms River, New Jersey, United States, 08753
        • XenoPort Clinical Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • XenoPort Clinical Site
    • New York
      • Albany, New York, United States, 12208
        • XenoPort Clinical Site
      • Patchogue, New York, United States, 11772
        • XenoPort Clinical Site
      • Plainview, New York, United States, 11803
        • XenoPort Clinical Site
    • North Carolina
      • Asheville, North Carolina, United States, 28805
        • XenoPort Clinical Site
    • Ohio
      • Akron, Ohio, United States, 44320
        • XenoPort Clinical Site
    • Tennessee
      • Franklin, Tennessee, United States, 37064
        • XenoPort Clinical Site
      • Nashville, Tennessee, United States, 37205
        • XenoPort Clinical Site
    • Texas
      • San Antonio, Texas, United States, 78206
        • XenoPort Clinical Site
    • Virginia
      • Vienna, Virginia, United States, 22181
        • XenoPort Clinical Site
    • Washington
      • Seattle, Washington, United States, 98108
        • XenoPort Clinical Site
      • Tacoma, Washington, United States, 98404
        • 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Has multiple sclerosis (MS) based on Poser or McDonald Criteria (all subtypes of MS will be accepted, including relapsing remitting, primary or secondary progressive, if disease is stable per exclusion criteria).
  2. Maximum Ashworth Score Scale score of ≥ 2 in at least one of the following muscle groups on either side of the body: hip abductors/adductors, knee flexors/extensors, ankle flexors/extensors.
  3. Expanded Disability Status Scale (EDSS) rating between 3.0-8.0 inclusive.
  4. If a subject is on disease modifying MS treatment, the dosage, frequency, and route of administration must be stable for at least 30 days before screening and is expected to be stable throughout the study.
  5. Spasticity Disability Rating of 2 or higher at Baseline.
  6. Willing to discontinue and refrain from using for the duration of the study drugs for the treatment of spasticity or likely to affect spasticity (including, but not limited to, baclofen, tizanidine, diazepam, clonazepam, metaxalone, dantrolene, cyclobenzaprine, carisoprodol, clonidine, vigabatrin, valproic acid and cannabis).

Exclusion Criteria:

  1. Spasticity due to neurological disorder other than MS or other conditions that may confound the assessment of spasticity.
  2. Subject has clinically evident muscle contractures resulting in irreversible spasticity in lower extremities.
  3. Subjects who have suffered an acute relapse of MS (as determined by the Investigator) within 90 days prior to Screening, or have had more than 1 relapse within the year prior to Screening
  4. Botulinum toxin injection within 6 months of Screening or has current residual associated side effects at Screening.
  5. Subjects receiving concomitant medication from more than one of the following three drug classes: (Antiepileptic drugs, Tricyclic anti-depressants and Opioids)

  6. Subjects on the following medications, at doses above the specified limits, are excluded if they cannot maintain a level within these limits

    • Gabapentin ≤ 1800 mg per day or pregabalin ≤ 150 mg per day
    • Amitriptyline ≤ 75 mg per day or nortriptyline ≤ 75 mg per day
    • Opioids ≤ 30 mg morphine equivalents per day.
  7. Evidence of unstable or severe systemic illness, including but not limited to: Cardiovascular disease (e.g., chronic ventricular arrhythmia, unstable angina or CHF), respiratory disease (e.g., sleep apnea, COPD requiring oxygen therapy or hospitalization in last year), endocrine disease, hepatic disease (e.g., chronic active hepatitis), renal disease, or immunodeficiency.

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: Parallel 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.
Active Comparator: Arbaclofen placarbil 15 mg BID
Arbaclofen placarbil (XP19986 SR4) 15 mg every morning and every evening
Drug: Arbaclofen placarbil 15 mg BID
arbaclofen placarbil 15 mg BID
Other Names:
  • XP19986 SR4
Active Comparator: Arbaclofen placarbil 30 mg BID
Arbaclofen placarbil (XP19986 SR4) 30 mg every morning and every evening
Drug: Arbaclofen placarbil 30 mg BID
arbaclofen placarbil 30 mg BID
Other Names:
  • XP19986 SR4
Active Comparator: Arbaclofen placarbil 45 mg BID
Arbaclofen placarbil (XP19986 SR4) 45 mg every morning and every evening
Drug: Arbaclofen placarbil 45 mg BID
arbaclofen placarbil 45 mg BID
Other Names:
  • XP19986 SR4
Placebo Comparator: Placebo
Placebo every morning and every evening
Drug: Placebo
Placebo for arbaclofen placarbil 15, 30 and 45 mg BID
Other Names:
  • Sugar Pill

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
Measure Description
Time Frame
Change from Baseline in Maximum Ashworth Scale score (6 hour post-dose time point)
Time Frame: 10-weeks
numerical score
10-weeks
Patient Global Impression of Change (PGIC) score
Time Frame: 10-weeks
numerical score
10-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
Measure Description
Time Frame
Change in the overall Modified PRISM score
Time Frame: Weeks 4, 6, 10
Variables
Weeks 4, 6, 10
Change in weekly average severity of pain score associated with muscle spasm.
Time Frame: Week 10
numerical score
Week 10
Change in weekly average VAS score of sleep quality
Time Frame: Week 10
numerical score
Week 10

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
May 1, 2011

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.
February 1, 2013

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.
February 1, 2013

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).
May 22, 2011

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.
May 23, 2011

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.
May 24, 2011

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 21, 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 17, 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-B-089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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