Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-02 @ 4:42 PM
Study NCT ID:
NCT00616733
Status:
COMPLETED
Last Update Posted:
2011-03-10
First Post:
2008-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C569297', 'term': 'CS 0777'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-09', 'studyFirstSubmitDate': '2008-02-04', 'studyFirstSubmitQcDate': '2008-02-04', 'lastUpdatePostDateStruct': {'date': '2011-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability.', 'timeFrame': '12 weeks, with 4 weeks to follow-up'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions)', 'timeFrame': '12 weeks, with 4 weeks to follow up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple sclerosis, relapsing, secondary progressive, clinically isolated syndrome, MRI'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of clinically isolated syndrome or a relapsing form(s) of MS, based on Poser or McDonald criteria (may include patients with secondary progressive disease)\n* Clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain MRI scan within the past 12 months\n* Baseline EDSS score of 0 - 6.5\n* Female subjects who are sexually active, unless sterile or post-menopausal for at least 1 year, must be willing to use double-barrier contraception\n\nExclusion Criteria:\n\n* Primary progressive MS\n* Any medical condition that predisposes to immunocompromise\n* History of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infection, or any current active infection\n* Concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or lupus)\n* Treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation\n* Treatment with cyclosporine, azathioprine, methotrexate or other immunosuppressant within 3 months of study initiation\n* Treatment with interferon beta or glatiramer acetate within 2 months of study initiation\n* Prior treatment with natalizumab or rituximab'}, 'identificationModule': {'nctId': 'NCT00616733', 'briefTitle': '12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'An Open-label, Escalating-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'CS0777-A-U102'}, 'secondaryIdInfos': [{'id': 'IND 77,409'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: CS-0777 tablets']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: CS-0777 tablets']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: CS-0777 tablets']}], 'interventions': [{'name': 'CS-0777 tablets', 'type': 'DRUG', 'description': '0.1 mg, once-weekly, for 12 weeks', 'armGroupLabels': ['1']}, {'name': 'CS-0777 tablets', 'type': 'DRUG', 'description': '0.3 mg, once-weekly or once every 2 weeks, for 12 weeks', 'armGroupLabels': ['2']}, {'name': 'CS-0777 tablets', 'type': 'DRUG', 'description': '0.6 mg, once-weekly or once every 2 weeks, for 12 weeks', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'James Moberly, PhD, Senior Director, Clinical Development', 'oldOrganization': 'Daiichi Sankyo, Inc.'}}}}