We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01359566
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01359566
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : February 21, 2021
Information provided by (Responsible Party):
XenoPort, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Arbaclofen placarbil 15 mg BID Drug: Placebo Drug: Arbaclofen placarbil 30 mg BID Drug: Arbaclofen placarbil 45 mg BID Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis
Study Start Date : May 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 Name: 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 Name: 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 Name: XP19986 SR4

Placebo Comparator: Placebo
Placebo every morning and every evening
Drug: Placebo
Placebo for arbaclofen placarbil 15, 30 and 45 mg BID
Other Name: Sugar Pill

Primary Outcome Measures :
  1. Change from Baseline in Maximum Ashworth Scale score (6 hour post-dose time point) [ Time Frame: 10-weeks ]
    numerical score

  2. Patient Global Impression of Change (PGIC) score [ Time Frame: 10-weeks ]
    numerical score

Secondary Outcome Measures :
  1. Change in the overall Modified PRISM score [ Time Frame: Weeks 4, 6, 10 ]

  2. Change in weekly average severity of pain score associated with muscle spasm. [ Time Frame: Week 10 ]
    numerical score

  3. Change in weekly average VAS score of sleep quality [ Time Frame: Week 10 ]
    numerical score

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359566

Layout table for location information
United States, Arizona
XenoPort Clinical Site
Phoenix, Arizona, United States, 85004
XenoPort Clinical Site
Tucson, Arizona, United States, 85701
United States, California
XenoPort Clinical Site
Berkeley, California, United States, 94705
XenoPort Clinical Site
San Diego, California, United States, 92103
United States, Colorado
XenoPort Clinical Site
Denver, Colorado, United States, 80012
United States, Florida
XenoPort Clinical Site
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
United States, Illinois
XenoPort Clinical Site
Lake Barrington, Illinois, United States, 60010
United States, Indiana
XenoPort Clinical Site
Indianapolis, Indiana, United States, 46204
United States, Kansas
XenoPort Clinical Site
Lenexa, Kansas, United States, 66210
United States, Kentucky
XenoPort Clinical Site
Lexington, Kentucky, United States, 40505
United States, Michigan
XenoPort Clinical Site
Bingham Farms, Michigan, United States, 48025
XenoPort Clinical Site
Detroit, Michigan, United States, 48202
United States, New Jersey
XenoPort Clinical Site
Toms River, New Jersey, United States, 08753
United States, New Mexico
XenoPort Clinical Site
Albuquerque, New Mexico, United States, 87102
United States, New York
XenoPort Clinical Site
Albany, New York, United States, 12208
XenoPort Clinical Site
Patchogue, New York, United States, 11772
XenoPort Clinical Site
Plainview, New York, United States, 11803
United States, North Carolina
XenoPort Clinical Site
Asheville, North Carolina, United States, 28805
United States, Ohio
XenoPort Clinical Site
Akron, Ohio, United States, 44320
United States, Tennessee
XenoPort Clinical Site
Franklin, Tennessee, United States, 37064
XenoPort Clinical Site
Nashville, Tennessee, United States, 37205
United States, Texas
XenoPort Clinical Site
San Antonio, Texas, United States, 78206
United States, Virginia
XenoPort Clinical Site
Vienna, Virginia, United States, 22181
United States, Washington
XenoPort Clinical Site
Seattle, Washington, United States, 98108
XenoPort Clinical Site
Tacoma, Washington, United States, 98404
Sponsors and Collaborators
XenoPort, Inc.
Layout table for investigator information
Study Director: Study Director Indivior Inc.
Additional Information:
Layout table for additonal information
Responsible Party: XenoPort, Inc.
ClinicalTrials.gov Identifier: NCT01359566    
Obsolete Identifiers: NCT01360489
Other Study ID Numbers: XP-B-089
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Arbaclofen placarbil
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action