Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis
NCT ID: NCT01359566
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
228 participants
INTERVENTIONAL
2011-05-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arbaclofen placarbil 15 mg BID
Arbaclofen placarbil (XP19986 SR4) 15 mg every morning and every evening
Arbaclofen placarbil 15 mg BID
arbaclofen placarbil 15 mg BID
Arbaclofen placarbil 30 mg BID
Arbaclofen placarbil (XP19986 SR4) 30 mg every morning and every evening
Arbaclofen placarbil 30 mg BID
arbaclofen placarbil 30 mg BID
Arbaclofen placarbil 45 mg BID
Arbaclofen placarbil (XP19986 SR4) 45 mg every morning and every evening
Arbaclofen placarbil 45 mg BID
arbaclofen placarbil 45 mg BID
Placebo
Placebo every morning and every evening
Placebo
Placebo for arbaclofen placarbil 15, 30 and 45 mg BID
Interventions
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Arbaclofen placarbil 15 mg BID
arbaclofen placarbil 15 mg BID
Placebo
Placebo for arbaclofen placarbil 15, 30 and 45 mg BID
Arbaclofen placarbil 30 mg BID
arbaclofen placarbil 30 mg BID
Arbaclofen placarbil 45 mg BID
arbaclofen placarbil 45 mg BID
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
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).
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.
18 Years
70 Years
ALL
No
Sponsors
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XenoPort, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Indivior Inc.
Locations
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XenoPort Clinical Site
Phoenix, Arizona, United States
XenoPort Clinical Site
Tucson, Arizona, United States
XenoPort Clinical Site
Berkeley, California, United States
XenoPort Clinical Site
San Diego, California, United States
XenoPort Clinical Site
Denver, Colorado, United States
XenoPort Clinical Site
Port Charlotte, Florida, United States
XenoPort Clinical Site
Sarasota, Florida, United States
XenoPort Clinical Site
St. Petersburg, Florida, United States
XenoPort Clinical Site
Tampa, Florida, United States
XenoPort Clinical Site
Lake Barrington, Illinois, United States
XenoPort Clinical Site
Indianapolis, Indiana, United States
XenoPort Clinical Site
Lenexa, Kansas, United States
XenoPort Clinical Site
Lexington, Kentucky, United States
XenoPort Clinical Site
Bingham Farms, Michigan, United States
XenoPort Clinical Site
Detroit, Michigan, United States
XenoPort Clinical Site
Toms River, New Jersey, United States
XenoPort Clinical Site
Albuquerque, New Mexico, United States
XenoPort Clinical Site
Albany, New York, United States
XenoPort Clinical Site
Patchogue, New York, United States
XenoPort Clinical Site
Plainview, New York, United States
XenoPort Clinical Site
Asheville, North Carolina, United States
XenoPort Clinical Site
Akron, Ohio, United States
XenoPort Clinical Site
Franklin, Tennessee, United States
XenoPort Clinical Site
Nashville, Tennessee, United States
XenoPort Clinical Site
San Antonio, Texas, United States
XenoPort Clinical Site
Vienna, Virginia, United States
XenoPort Clinical Site
Seattle, Washington, United States
XenoPort Clinical Site
Tacoma, Washington, United States
Countries
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Related Links
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The Command Clinical Research Trial Website
Other Identifiers
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XP-B-089
Identifier Type: -
Identifier Source: org_study_id
NCT01360489
Identifier Type: -
Identifier Source: nct_alias
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