Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-29 @ 6:07 AM
Study NCT ID:
NCT00947895
Status:
TERMINATED
Last Update Posted:
2016-03-22
First Post:
2009-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D012598', 'term': '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}, {'id': 'D000324', 'term': 'Adrenocorticotropic Hormone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D053486', 'term': 'Melanocortins'}, {'id': 'D011333', 'term': 'Pro-Opiomelanocortin'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Study reached halfway point in approximately one year time period and was halted to analyze data.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-21', 'studyFirstSubmitDate': '2009-07-02', 'studyFirstSubmitQcDate': '2009-07-27', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities).', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Improvement in MSFC (Multiple Sclerosis Functional Composite)18 and its three individual components.', 'timeFrame': '12 weeks'}, {'measure': 'Safety and tolerability of ACTH and MP in patients with an acute relapse of multiple sclerosis after sub-response to an initial course of intravenous methylprednisolone.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ACTH', 'Acthar gel', 'adrenocorticotropin', 'methylprednisolone', 'solumedrol', 'MS', 'multiple', 'sclerosis', 'relapse', 'exacerbation', 'sub-responsive', 'IV'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.neurologique.org', 'label': 'Study sponsor website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare intramuscular (IM) ACTH (adrenocorticotropin hormone) and intravenous (IV) methylprednisolone (Solumedrol) for the treatment of an MS (Multiple Sclerosis) relapse (exacerbation) after sub-response to an initial 3 day course of IV methylprednisolone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male or female\n\n * females of childbearing potential must:\n\n * have negative pregnancy tests prior to entry into the Double-blind Treatment Phase\n * agree to use adequate contraception during the treatment.\n * females who are either post-menopausal for 12 months prior to randomization or surgically sterile (if documented), may be included without above requirements\n* ≥ 18 years of age\n* sign written informed consent prior to participating in the study (Appendix 1)\n* willing and able to comply with trial requirements, including visit schedule and completion of scales\n* diagnosis of multiple sclerosis by 2005 revised McDonald criteria (Appendix 3)\n* an Expanded Disability Status Scale (EDSS) score of 0-6.0 inclusive\n* currently taking a stable dose of an injectable MS disease modifying agent for the preceding 6 months or greater prior to the study-entry relapse\n* in the opinion of their treating physician should undergo a 3 - 5 day course of IV methylprednisolone\n\nExclusion Criteria:\n\n* a manifestation of MS other than relapsing\n* initial IV MP greater than 14 days after from start of presenting relapse\n* a history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome\n* a known or 'new' diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes \\[≥126 mg/dL or ≥7 mmol/L if fasting; ≥200 mg/dL or 11.1 mmol/L if random testing\\] a patient should be further evaluated for diabetes mellitus)\n* a contraindication to steroid therapy, e.g., peptic ulcer, psychotic states or severe hypertension\n* sensitivity to proteins of porcine origin\n* a known or 'new' diagnosis of severe depression as defined by a score greater than 30 on the Beck Depression Inventory (BDI)\n* a known or 'new' diagnosis of hypothyroidism not adequately controlled with medication\n* treatment with Natalizumab in the past 6 months\n* active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively\n* have received total lymphoid irradiation or bone marrow transplantation\n* have been treated with corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to Pre-Randomization Phase\n* any medically unstable condition, as assessed by the primary treating physician\n* any of the following neurologic/psychiatric disorders:\n\n * history of substance abuse (drug or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject's ability to cooperate and comply with the study procedures;\n * progressive neurological disorder, other than MS, which may affect participation in the study or require the use of medications not allowed by the protocol\n* any of the following abnormal laboratory values:\n\n * serum creatinine greater than 1.7 mg/dL (150 μmol/L)\n * white blood cell (WBC) count \\<3,500/mm3 (\\<3.5 X 109 / L)\n * lymphocyte count \\<800/mm3 (\\<0.8 X 109 / L)"}, 'identificationModule': {'nctId': 'NCT00947895', 'acronym': 'RECLAIM', 'briefTitle': 'Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone', 'organization': {'class': 'OTHER', 'fullName': 'Neurologique Foundation, Inc.'}, 'officialTitle': 'Relative Efficacy of Repeat Course of Intravenous methyLprednisolone and Intramuscular ACTH in the Treatment of Acute Relapse of Multiple Sclerosis After Sub Response to Initial Course of Intravenous Methylprednisolone (RECLAIM): a Single Center Pilot Study', 'orgStudyIdInfo': {'id': 'Q1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisolone', 'description': 'Intravenous (IV) methylprednisolone (Solumedrol) 1000 mg daily for 3 days.', 'interventionNames': ['Drug: Methylprednisolone', 'Other: IM placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ACTH', 'description': 'Intramuscular (IM) ACTH 80 mg/day for 5 days.', 'interventionNames': ['Drug: ACTH', 'Other: IV placebo']}], 'interventions': [{'name': 'Methylprednisolone', 'type': 'DRUG', 'otherNames': ['Solumedrol'], 'description': 'IV 1000 mg daily for 3 days', 'armGroupLabels': ['Methylprednisolone']}, {'name': 'ACTH', 'type': 'DRUG', 'otherNames': ['H.P. Acthar Gel', 'Repository corticotropin injection', 'Adrenocorticotropin hormone'], 'description': 'IM ACTH 80 mg/day for 5 days.', 'armGroupLabels': ['ACTH']}, {'name': 'IV placebo', 'type': 'OTHER', 'description': 'IV placebo (saline) daily for 3 days.', 'armGroupLabels': ['ACTH']}, {'name': 'IM placebo', 'type': 'OTHER', 'description': 'IM placebo (saline) daily for 5 days.', 'armGroupLabels': ['Methylprednisolone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32082', 'city': 'Ponte Vedra', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurologique Foundation, Inc.', 'geoPoint': {'lat': 30.22746, 'lon': -81.38008}}], 'overallOfficials': [{'name': 'Daniel Kantor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neurologique Foundation, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurologique Foundation, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mallinckrodt', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}