Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 12:23 AM
Study NCT ID:
NCT01359566
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2011-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543531', 'term': 'arbaclofen placarbil'}, {'id': 'C494814', 'term': 'BID protein, human'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'dispFirstSubmitDate': '2015-12-28', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2011-05-22', 'dispFirstSubmitQcDate': '2015-12-28', 'studyFirstSubmitQcDate': '2011-05-23', 'dispFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Maximum Ashworth Scale score (6 hour post-dose time point)', 'timeFrame': '10-weeks', 'description': 'numerical score'}, {'measure': 'Patient Global Impression of Change (PGIC) score', 'timeFrame': '10-weeks', 'description': 'numerical score'}], 'secondaryOutcomes': [{'measure': 'Change in the overall Modified PRISM score', 'timeFrame': 'Weeks 4, 6, 10', 'description': 'Variables'}, {'measure': 'Change in weekly average severity of pain score associated with muscle spasm.', 'timeFrame': 'Week 10', 'description': 'numerical score'}, {'measure': 'Change in weekly average VAS score of sleep quality', 'timeFrame': 'Week 10', 'description': 'numerical score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ispot.tv/ad/7LIc/command-clinical-research-study-ms-spasticity', 'label': 'The Command Clinical Research Trial Website'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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).\n2. 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.\n3. Expanded Disability Status Scale (EDSS) rating between 3.0-8.0 inclusive.\n4. 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.\n5. Spasticity Disability Rating of 2 or higher at Baseline.\n6. 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).\n\nExclusion Criteria:\n\n1. Spasticity due to neurological disorder other than MS or other conditions that may confound the assessment of spasticity.\n2. Subject has clinically evident muscle contractures resulting in irreversible spasticity in lower extremities.\n3. 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\n4. Botulinum toxin injection within 6 months of Screening or has current residual associated side effects at Screening.\n5. Subjects receiving concomitant medication from more than one of the following three drug classes: (Antiepileptic drugs, Tricyclic anti-depressants and Opioids)\n6. Subjects on the following medications, at doses above the specified limits, are excluded if they cannot maintain a level within these limits\n\n * Gabapentin ≤ 1800 mg per day or pregabalin ≤ 150 mg per day\n * Amitriptyline ≤ 75 mg per day or nortriptyline ≤ 75 mg per day\n * Opioids ≤ 30 mg morphine equivalents per day.\n7. 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.'}, 'identificationModule': {'nctId': 'NCT01359566', 'briefTitle': 'Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis', 'nctIdAliases': ['NCT01360489'], 'organization': {'class': 'INDUSTRY', 'fullName': 'XenoPort, Inc.'}, 'officialTitle': 'A Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'XP-B-089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arbaclofen placarbil 15 mg BID', 'description': 'Arbaclofen placarbil (XP19986 SR4) 15 mg every morning and every evening', 'interventionNames': ['Drug: Arbaclofen placarbil 15 mg BID']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arbaclofen placarbil 30 mg BID', 'description': 'Arbaclofen placarbil (XP19986 SR4) 30 mg every morning and every evening', 'interventionNames': ['Drug: Arbaclofen placarbil 30 mg BID']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arbaclofen placarbil 45 mg BID', 'description': 'Arbaclofen placarbil (XP19986 SR4) 45 mg every morning and every evening', 'interventionNames': ['Drug: Arbaclofen placarbil 45 mg BID']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo every morning and every evening', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Arbaclofen placarbil 15 mg BID', 'type': 'DRUG', 'otherNames': ['XP19986 SR4'], 'description': 'arbaclofen placarbil 15 mg BID', 'armGroupLabels': ['Arbaclofen placarbil 15 mg BID']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar Pill'], 'description': 'Placebo for arbaclofen placarbil 15, 30 and 45 mg BID', 'armGroupLabels': ['Placebo']}, {'name': 'Arbaclofen placarbil 30 mg BID', 'type': 'DRUG', 'otherNames': ['XP19986 SR4'], 'description': 'arbaclofen placarbil 30 mg BID', 'armGroupLabels': ['Arbaclofen placarbil 30 mg BID']}, {'name': 'Arbaclofen placarbil 45 mg BID', 'type': 'DRUG', 'otherNames': ['XP19986 SR4'], 'description': 'arbaclofen placarbil 45 mg BID', 'armGroupLabels': ['Arbaclofen placarbil 45 mg BID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85701', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80012', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33948', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '34231', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33604', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60010', 'city': 'Lake Barrington', 'state': 'Illinois', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 42.21252, 'lon': -88.15258}}, {'zip': '46204', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66210', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '40505', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '48025', 'city': 'Bingham Farms', 'state': 'Michigan', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 42.51587, 'lon': -83.27326}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '08753', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11772', 'city': 'Patchogue', 'state': 'New York', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 40.76565, 'lon': -73.01511}}, {'zip': '11803', 'city': 'Plainview', 'state': 'New York', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 40.77649, 'lon': -73.46735}}, {'zip': '28805', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '44320', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '37064', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78206', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22181', 'city': 'Vienna', 'state': 'Virginia', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 38.90122, 'lon': -77.26526}}, {'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98404', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'XenoPort Clinical Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Indivior Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'XenoPort, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}