Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-29 @ 10:41 AM
Study NCT ID:
NCT01649050
Status:
WITHDRAWN
Last Update Posted:
2017-04-20
First Post:
2012-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591013', 'term': 'selurampanel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-19', 'studyFirstSubmitDate': '2012-07-06', 'studyFirstSubmitQcDate': '2012-07-20', 'lastUpdatePostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in spasticity NRS score from baseline to 5 weeks', 'timeFrame': '5 weeks', 'description': 'The spasticity Numeric Rating Scale is a 0 to 10 patient reported scale of spasticity severity, with 0 being no spasticity and 10 being worst possible spasticity.'}, {'measure': 'PGIC score at 5 weeks', 'timeFrame': '5 weeks', 'description': 'The Patient Global Impression of Change is a patient reported one item mesaure of overall improvement in condition since the previous visit. The patient is asked to choose one of 7 sentences from very much improved to very much worse, that best describes his present condition.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to 5 weeks in Ashworth spasticity score', 'timeFrame': '5 weeks', 'description': 'The Ashworth spasticity score is a physician assessed rating of spasticity using a five point score from 0 to 4 for each muscle group tested.'}, {'measure': 'Safety and tolerability', 'timeFrame': 'average of 70 days, maximum from day -19 to day 52, i.e. from first baseline up to study completion visit', 'description': 'Number of patients with adverse events (AE).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spasticity', 'Multiple Sclerosis'], 'conditions': ['Muscle Spasticity Due to Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'To evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity due to multiple sclerosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diagnosis of multiple sclerosis (MS) of any type.\n* MS diagnosis at least 6 months prior to screening.\n* Stable MS with no relapse within 3 months prior to screening.\n* Treated or untreated spasticity due to MS for at least 3 months prior to screening, not wholly relieved with antispasticity medications.\n\nKey exclusion criteria:\n\n* Patients with symptoms of spasticity not due to MS.\n* Patients taking three or more different anti-spasticity medications.\n* Acute MS exacerbation requiring treatment within 3 months of the Screening Visit.\n* Initiation of, or the discontinuation of interferon beta or any other disease modifying therapy for MS within 3 months of the Screening Visit.\n* Use of baclofen pump at any time.\n* Wheelchair or bed-bound patients.'}, 'identificationModule': {'nctId': 'NCT01649050', 'briefTitle': 'Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Assess the Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'CBGG492A2215'}, 'secondaryIdInfos': [{'id': '2012-002783-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BGG492', 'description': 'BGG492 tablets administered orally', 'interventionNames': ['Drug: BGG492']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo administered orally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BGG492', 'type': 'DRUG', 'armGroupLabels': ['BGG492']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}