Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT01950234
Status:
TERMINATED
Last Update Posted:
2025-02-11
First Post:
2013-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ACTH in Progressive Forms of MS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}], '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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000324', 'term': 'Adrenocorticotropic Hormone'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hilbe010@umn.edu', 'phone': '612-624-7745', 'title': 'Sarah Hikbert', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '36 Months', 'eventGroups': [{'id': 'EG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 29, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 29, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dermatologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 24, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 26, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 25, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 22, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic/endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 83, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 46, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 38, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 17, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients Exhibiting a 20% Worsening in T25FW at 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Menstrual Changes [Female]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study noticing any changes in menstrual cycle or period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: DEXA Scans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 36', 'description': "The number is a T-score. There is no maximum or minimum value. Mean change in average of 5 DEXA scan values dual-energy x-ray absorptiometry; measures bone mineral density. Higher numbers are better.\n\nA DEXA T-score has a mean of 0 and standard deviation of 1, meaning that a T-score represents how many standard deviations a person's bone density is away from the average bone density of a healthy young adult, with a score of 0 indicating average bone density. Higher scores are better, indicating better bone density. A T-score of -1 to +1 is considered normal bone density, a score between -1 and -2.5 indicates osteopenia (low bone mass), and a score of -2.5 or lower indicates osteoporosis.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Bruising', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that they bruise more easily', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Swelling Ankles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that have noticed swelling in their ankles', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Hair Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that have noticed losing more hair', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Acne', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that have noticed in increase in acne', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that they have been having trouble sleeping', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Mood Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that they have noticed changes in mood', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: GI Upset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that they have had upset stomach, indigestion, diarrhea, or bloating', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that noticed feeling tired or worn out', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Unpleasant Taste', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study noticing a metallic taste in their mouth', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Blurred Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study noticing any blurred vision', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Moon Facies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'New physician assessed moon facies over study duration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Skin Thinning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'New physician assessed skin thinning over study duration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Hirsuitism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'New physician assessed hirsuitism over study duration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Bruising', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'New physician assessed bruising over study duration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Ankle Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'New physician assessed ankle swelling over study duration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Hair Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'Any new physician assessed hair loss over study duration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Cataracts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'New physician assessed cataracts over study duration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Myopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36', 'description': 'New physician assessed myopathy over study duration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of ACTH: Change in Hemoglobin A1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 36', 'description': 'Change in hemoglobin A1c', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month\n\nACTH: Acthar gel'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month\n\nPlacebo: Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '51.5', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '53.9', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-26', 'size': 611840, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-26T08:37', 'hasProtocol': True}, {'date': '2019-07-22', 'size': 419974, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-26T08:43', 'hasProtocol': False}]}}, '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': 59}}, 'statusModule': {'whyStopped': 'The funding source discontinued financial support for the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2013-08-30', 'resultsFirstSubmitDate': '2024-07-26', 'studyFirstSubmitQcDate': '2013-09-20', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-10', 'studyFirstPostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Exhibiting a 20% Worsening in T25FW at 36 Months', 'timeFrame': 'Month 36'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability of ACTH: Menstrual Changes [Female]', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study noticing any changes in menstrual cycle or period.'}, {'measure': 'Safety and Tolerability of ACTH: DEXA Scans', 'timeFrame': 'Month 36', 'description': "The number is a T-score. There is no maximum or minimum value. Mean change in average of 5 DEXA scan values dual-energy x-ray absorptiometry; measures bone mineral density. Higher numbers are better.\n\nA DEXA T-score has a mean of 0 and standard deviation of 1, meaning that a T-score represents how many standard deviations a person's bone density is away from the average bone density of a healthy young adult, with a score of 0 indicating average bone density. Higher scores are better, indicating better bone density. A T-score of -1 to +1 is considered normal bone density, a score between -1 and -2.5 indicates osteopenia (low bone mass), and a score of -2.5 or lower indicates osteoporosis."}, {'measure': 'Safety and Tolerability of ACTH: Bruising', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that they bruise more easily'}, {'measure': 'Safety and Tolerability of ACTH: Swelling Ankles', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that have noticed swelling in their ankles'}, {'measure': 'Safety and Tolerability of ACTH: Hair Loss', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that have noticed losing more hair'}, {'measure': 'Safety and Tolerability of ACTH: Acne', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that have noticed in increase in acne'}, {'measure': 'Safety and Tolerability of ACTH: Insomnia', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that they have been having trouble sleeping'}, {'measure': 'Safety and Tolerability of ACTH: Mood Change', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that they have noticed changes in mood'}, {'measure': 'Safety and Tolerability of ACTH: GI Upset', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that they have had upset stomach, indigestion, diarrhea, or bloating'}, {'measure': 'Safety and Tolerability of ACTH: Fatigue', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study that noticed feeling tired or worn out'}, {'measure': 'Safety and Tolerability of ACTH: Unpleasant Taste', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study noticing a metallic taste in their mouth'}, {'measure': 'Safety and Tolerability of ACTH: Blurred Vision', 'timeFrame': 'Month 36', 'description': 'Count of participants self reporting at any time throuhgout the study noticing any blurred vision'}, {'measure': 'Safety and Tolerability of ACTH: Moon Facies', 'timeFrame': 'Month 36', 'description': 'New physician assessed moon facies over study duration'}, {'measure': 'Safety and Tolerability of ACTH: Skin Thinning', 'timeFrame': 'Month 36', 'description': 'New physician assessed skin thinning over study duration'}, {'measure': 'Safety and Tolerability of ACTH: Hirsuitism', 'timeFrame': 'Month 36', 'description': 'New physician assessed hirsuitism over study duration'}, {'measure': 'Safety and Tolerability of ACTH: Bruising', 'timeFrame': 'Month 36', 'description': 'New physician assessed bruising over study duration'}, {'measure': 'Safety and Tolerability of ACTH: Ankle Swelling', 'timeFrame': 'Month 36', 'description': 'New physician assessed ankle swelling over study duration'}, {'measure': 'Safety and Tolerability of ACTH: Hair Loss', 'timeFrame': 'Month 36', 'description': 'Any new physician assessed hair loss over study duration'}, {'measure': 'Safety and Tolerability of ACTH: Cataracts', 'timeFrame': 'Month 36', 'description': 'New physician assessed cataracts over study duration'}, {'measure': 'Safety and Tolerability of ACTH: Myopathy', 'timeFrame': 'Month 36', 'description': 'New physician assessed myopathy over study duration'}, {'measure': 'Safety and Tolerability of ACTH: Change in Hemoglobin A1c', 'timeFrame': 'Month 36', 'description': 'Change in hemoglobin A1c'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Secondary Progressive Multiple Sclerosis', 'Primary Progressive Multiple Sclerosis', 'Progressive Relapsing Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This is a phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of adrenocorticotropic hormone (ACTH, Acthar gel) administered as a pulsed regimen consisting of injections on three consecutive days per month in patients with progressive forms of Multiple Sclerosis (MS). Patients will be randomly assigned to either an ACTH arm or a placebo arm. The main hypotheses are that 1) pulsed ACTH will be safe and well-tolerated, and 2) pulsed ACTH will slow progression of clinical and paraclinical measures of MS progression compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients with a confirmed diagnosis of MS by McDonald criteria\n* Age \\>/= 18 years\n* SPMS, PPMS, or PRMS phenotype, according to Lublin and Reingold criteria\n* EDSS 2.0 - 6.0, inclusive\n* Able to understand the consent process\n\nExclusion Criteria:\n\n* Known intolerance of ACTH or corticosteroids\n* Diabetes mellitus, defined as pre-existing diagnosis, fasting blood glucose \\> 125 mg/dl, or glycosylated hemoglobin \\>/= 6.5%\n* Osteoporosis, defined as pre-existing diagnosis or T-score on dual-energy x-ray absorptiometry (DEXA) scan of \\</= -2.5.\n* Current serious medical condition which may interfere with subject's ability to complete the study, or for which pulsed ACTH therapy is contraindicated or might complicate current therapy (e.g., cancer, severe psychiatric illness, chronic infections, autoimmune disorders)\n* Treatment with cytotoxic agents (including but not necessarily limited to mitoxantrone, cyclophosphamide, alemtuzumab, or rituximab) within 3 years prior to randomization\n* Treatment with non-cytotoxic immunosuppressive agents (including but not necessarily limited to corticosteroids, ACTH, azathioprine, mycophenolate mofetil, methotrexate or natalizumab) within 3 months prior to randomization\n* Treatment with FDA-approved first-line MS disease-modifying therapies (B-interferon, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) will be permitted, as long as treatment has been ongoing and stable for at least 3 months prior to randomization\n* Treatment with dalfampridine or compounded 4-aminopyridine (4-AP) will be permitted as long as treatment has been ongoing and stable for at least 3 months prior to randomization\n* Stimulant medications for fatigue (such as methylphenidate, modafinil, armodafinil, amantadine or dextroamphetamine) will be permitted, but subjects will be asked to not take these medications on study visit days until all study procedures/assessments are completed."}, 'identificationModule': {'nctId': 'NCT01950234', 'briefTitle': 'ACTH in Progressive Forms of MS', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Treatment of Progressive Forms of Multiple Sclerosis With Pulsed ACTH (Acthar Gel)', 'orgStudyIdInfo': {'id': '110271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACTH', 'description': 'ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month', 'interventionNames': ['Drug: ACTH']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo subcutaneous injections administered on 3 consecutive days per month', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ACTH', 'type': 'DRUG', 'otherNames': ['Acthar gel'], 'description': 'Acthar gel', 'armGroupLabels': ['ACTH']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Clinical Neuroscience Research Unit, University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Sanford Clinic Neuroscience', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Wheaton Franciscan Healthcare - St Francis Center for Neurological Disorders', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Adam F Carpenter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mallinckrodt', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}