Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT00004802
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020513', 'term': 'Paralysis, Hyperkalemic Periodic'}, {'id': 'D020514', 'term': 'Hypokalemic Periodic Paralysis'}, {'id': 'D020967', 'term': 'Myotonic Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D010245', 'term': 'Paralyses, Familial Periodic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008664', 'term': 'Metal Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004005', 'term': 'Dichlorphenamide'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1992-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1998-01', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2000-02-24', 'studyFirstSubmitQcDate': '2000-02-24', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-02-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['neurologic and psychiatric disorders', 'periodic paralysis', 'rare disease'], 'conditions': ['Paralysis, Hyperkalemic Periodic', 'Hypokalemic Periodic Paralysis', 'Paramyotonia Congenita']}, 'descriptionModule': {'briefSummary': 'OBJECTIVES:\n\nI. Assess the efficacy of dichlorphenamide in the treatment of episodic weakness attacks in patients with hyperkalemic periodic paralysis, paramyotonia congenita with periodic paralysis, and hypokalemic periodic paralysis.', 'detailedDescription': 'PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution and diagnosis.\n\nThe weekly attack rate is determined during an 8-week assessment prior to therapy initiation and at crossover.\n\nPatients are randomly assigned to oral dichlorphenamide (DCP) or placebo for 9 weeks and then cross to the alternate treatment. Patients on DCP at baseline continue on the same dose; those on acetazolamide (ACZ) at baseline receive a DCP dose equivalent to one fifth of the ACZ dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'PROTOCOL ENTRY CRITERIA:\n\n--Disease Characteristics--\n\nHypokalemic periodic paralysis Typical clinical profile Normal serum thyroxine Hypokalemia during spontaneous or glucose-induced paralytic attack in subject or affected family member\n\nPeriodic paralysis associated with sodium channel 17q alpha-subunit, e.g.:\n\n* Hyperkalemic periodic paralysis with or without myotonia\n* Paramyotonia congenita with periodic paralysis\n\nDistinct, regular episodes of weakness at least once a week and no more than 3 times a day\n\nNo history of worsening symptoms with carbonic anhydrase inhibitor\n\nNo history of life-threatening weakness episodes prior to treatment\n\nNo atypical periodic paralysis without demonstrable 17q alpha-subunit defect\n\n--Prior/Concurrent Therapy--\n\nNo requirement for the following agents, unless for periodic paralysis:\n\n* Diuretics\n* Antiepileptics\n* Antiarrhythmics\n* Magnesium supplements\n* Steroids\n* Calcium supplements\n* Beta-blockers\n* Potassium supplements\n* Calcium channel blockers\n\n--Patient Characteristics--\n\nHepatic: No hepatic disease\n\nRenal:\n\n* No renal failure\n* No nephrolithiasis\n\nCardiovascular:\n\n* No heart disease\n* No cardiac arrhythmia\n\nPulmonary: No restrictive or obstructive lung disease\n\nOther:\n\n* No active thyroid disease\n* No pregnant women'}, 'identificationModule': {'nctId': 'NCT00004802', 'briefTitle': 'Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders', 'organization': {'class': 'NIH', 'fullName': 'Office of Rare Diseases (ORD)'}, 'orgStudyIdInfo': {'id': '199/11958'}, 'secondaryIdInfos': [{'id': 'OSU-92H0173'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'dichlorphenamide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jerry R. Mendell', 'role': 'STUDY_CHAIR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, 'collaborators': [{'name': 'Ohio State University', 'class': 'OTHER'}]}}}