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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arbaclofen placarbil 15 mg BID | Active Comparator | Arbaclofen placarbil (XP19986 SR4) 15 mg every morning and every evening |
|
| Arbaclofen placarbil 30 mg BID | Active Comparator | Arbaclofen placarbil (XP19986 SR4) 30 mg every morning and every evening |
|
| Arbaclofen placarbil 45 mg BID | Active Comparator | Arbaclofen placarbil (XP19986 SR4) 45 mg every morning and every evening |
|
| Placebo | Placebo Comparator | Placebo every morning and every evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arbaclofen placarbil 15 mg BID | Drug | arbaclofen placarbil 15 mg BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Maximum Ashworth Scale score (6 hour post-dose time point) | numerical score | 10-weeks |
| Patient Global Impression of Change (PGIC) score | numerical score | 10-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the overall Modified PRISM score | Variables | Weeks 4, 6, 10 |
| Change in weekly average severity of pain score associated with muscle spasm. | numerical score |
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Inclusion Criteria:
Exclusion Criteria:
Spasticity due to neurological disorder other than MS or other conditions that may confound the assessment of spasticity.
Subject has clinically evident muscle contractures resulting in irreversible spasticity in lower extremities.
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
Botulinum toxin injection within 6 months of Screening or has current residual associated side effects at Screening.
Subjects receiving concomitant medication from more than one of the following three drug classes: (Antiepileptic drugs, Tricyclic anti-depressants and Opioids)
Subjects on the following medications, at doses above the specified limits, are excluded if they cannot maintain a level within these limits
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.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Indivior Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| XenoPort Clinical Site | Phoenix | Arizona | 85004 | United States | ||
| XenoPort Clinical Site |
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| Label | URL |
|---|---|
| The Command Clinical Research Trial Website | View source |
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| Placebo | Drug | Placebo for arbaclofen placarbil 15, 30 and 45 mg BID |
|
|
| Arbaclofen placarbil 30 mg BID | Drug | arbaclofen placarbil 30 mg BID |
|
|
| Arbaclofen placarbil 45 mg BID | Drug | arbaclofen placarbil 45 mg BID |
|
|
| Week 10 |
| Change in weekly average VAS score of sleep quality | numerical score | Week 10 |
| Tucson |
| Arizona |
| 85701 |
| United States |
| XenoPort Clinical Site | Berkeley | California | 94705 | United States |
| XenoPort Clinical Site | San Diego | California | 92103 | United States |
| XenoPort Clinical Site | Denver | Colorado | 80012 | United States |
| XenoPort Clinical Site | Port Charlotte | Florida | 33948 | United States |
| XenoPort Clinical Site | Sarasota | Florida | 34231 | United States |
| XenoPort Clinical Site | St. Petersburg | Florida | 33701 | United States |
| XenoPort Clinical Site | Tampa | Florida | 33604 | United States |
| XenoPort Clinical Site | Lake Barrington | Illinois | 60010 | United States |
| XenoPort Clinical Site | Indianapolis | Indiana | 46204 | United States |
| XenoPort Clinical Site | Lenexa | Kansas | 66210 | United States |
| XenoPort Clinical Site | Lexington | Kentucky | 40505 | United States |
| XenoPort Clinical Site | Bingham Farms | Michigan | 48025 | United States |
| XenoPort Clinical Site | Detroit | Michigan | 48202 | United States |
| XenoPort Clinical Site | Toms River | New Jersey | 08753 | United States |
| XenoPort Clinical Site | Albuquerque | New Mexico | 87102 | United States |
| XenoPort Clinical Site | Albany | New York | 12208 | United States |
| XenoPort Clinical Site | Patchogue | New York | 11772 | United States |
| XenoPort Clinical Site | Plainview | New York | 11803 | United States |
| XenoPort Clinical Site | Asheville | North Carolina | 28805 | United States |
| XenoPort Clinical Site | Akron | Ohio | 44320 | United States |
| XenoPort Clinical Site | Franklin | Tennessee | 37064 | United States |
| XenoPort Clinical Site | Nashville | Tennessee | 37205 | United States |
| XenoPort Clinical Site | San Antonio | Texas | 78206 | United States |
| XenoPort Clinical Site | Vienna | Virginia | 22181 | United States |
| XenoPort Clinical Site | Seattle | Washington | 98108 | United States |
| XenoPort Clinical Site | Tacoma | Washington | 98404 | United States |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C543531 | arbaclofen placarbil |
| C494814 | BID protein, human |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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