Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-31 @ 4:08 PM
Study NCT ID:
NCT00349193
Status:
COMPLETED
Last Update Posted:
2011-04-08
First Post:
2006-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'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'}]}}, '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': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2006-06-26', 'studyFirstSubmitQcDate': '2006-07-05', 'lastUpdatePostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of brain lesions in the last 4 months of the study', 'timeFrame': '36 weeks'}], 'secondaryOutcomes': [{'measure': 'Relapse rate', 'timeFrame': '36 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Relapsing Remitting Multiple Sclerosis'], 'conditions': ['Relapsing Remitting Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '18572078', 'type': 'DERIVED', 'citation': 'Comi G, Pulizzi A, Rovaris M, Abramsky O, Arbizu T, Boiko A, Gold R, Havrdova E, Komoly S, Selmaj K, Sharrack B, Filippi M; LAQ/5062 Study Group. Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study. Lancet. 2008 Jun 21;371(9630):2085-92. doi: 10.1016/S0140-6736(08)60918-6.'}]}, 'descriptionModule': {'briefSummary': 'Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has immunomodulating properties. In a previous clinical study laquinimod showed evidence of biological activity by reducing the number of acute brain lesions.\n\nThe duration of the current study is 36 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing and able to give written informed consent\n2. Confirmed MS diagnosis as defined by the McDonald criteria\n3. R-R MS disease course.\n4. At least one gadolinium-enhanced lesion on screening MRI\n5. Women of child-bearing potential must practice a reliable method of birth control.\n6. Must understand the requirements of the study and agree to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Subjects who suffer from any form of progressive MS.\n2. Any condition which the investigator feels may interfere with participation in the study.\n3. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation,\n4. Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening\n5. Previous treatment with immunomodulators within two months prior to screening'}, 'identificationModule': {'nctId': 'NCT00349193', 'briefTitle': 'A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Multinational, Multicenter Randomized Double-Blind, Parallel-Group, Placebo-Controlled Study, to Evaluate the Efficacy, Tolerability and Safety of Two Doses of, Oral Laquinimod in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects', 'orgStudyIdInfo': {'id': 'LAQ/5062'}, 'secondaryIdInfos': [{'id': '2004-003943-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laquinimod 0.3 mg', 'description': 'Laquinimod 0.3 mg', 'interventionNames': ['Drug: laquinimod 0.3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laquinimod 0.6 mg', 'description': 'Laquinimod 0.6 mg', 'interventionNames': ['Drug: laquinimod 0.6']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Blinded Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'laquinimod 0.3', 'type': 'DRUG', 'description': 'laquinimod 0.3mg', 'armGroupLabels': ['Laquinimod 0.3 mg']}, {'name': 'laquinimod 0.6', 'type': 'DRUG', 'description': 'laquinimod 0.6mg', 'armGroupLabels': ['Laquinimod 0.6 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Blinded Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Prof. Giancarlo Comi', 'role': 'STUDY_CHAIR', 'affiliation': 'Teva Pharmaceutical Industries, Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Ekkehard Baader, MD', 'oldOrganization': 'Teva Pharmaceutical Europe B.V.'}}}}