Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-03-01 @ 9:46 AM
Study NCT ID:
NCT00676156
Status:
COMPLETED
Last Update Posted:
2012-11-06
First Post:
2008-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008063', 'term': 'Thioctic Acid'}, {'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-02', 'studyFirstSubmitDate': '2008-05-07', 'studyFirstSubmitQcDate': '2008-05-07', 'lastUpdatePostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the pharmacokinetics of orally administered LA 1200 mg. This will assess the variability in bioavailability of LA and the feasibility of conducting a more focused PK assessment in future studies with LA.', 'timeFrame': 'November 2008'}], 'secondaryOutcomes': [{'measure': 'To study salivary LA concentrations corresponding to the serum levels.', 'timeFrame': 'November 2008'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'lipoic acid', 'LA', 'pharmacokinetics', 'immunological effects'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn about an investigational drug known as oral lipoic acid (LA) that may help treat multiple sclerosis. This study will measure how a person's body absorbs and breaks down the drug (pharmacokinetics) and will compare four different forms of the drug from four different manufacturers as well as LA in conjunction with fish oil.", 'detailedDescription': 'Multiple sclerosis (MS) is a common, often disabling inflammatory disease of the central nervous system (CNS). Present treatments for MS are only partially effective, available only in injectable forms, have significant side effects and are very costly. Developing more effective and better-tolerated treatments of MS thus remains an important goal for the improvement of the care of MS. Lipoic acid (LA) is an antioxidant that is widely available as a dietary supplement.\n\nThe primary outcome of this study is to determine the pharmacokinetics of oral LA 1200 mg to see if we can identify factors affecting the bioavailability of LA. We will also study the salivary concentrations of oral LA and its correlation with the serum LA concentrations. We will also study the effects of LA on the immunological markers after four hours of administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Definite MS by McDonald's or Poser's criteria\n* EDSS ≤ 7.5\n* Age 18 to 80\n\nExclusion Criteria:\n\n* No clinically significant MS exacerbation within 30 days of the screening\n* No systemically administered corticosteroids within 30 days of study entry\n* Patient not pregnant or breast feeding\n* No LA in previous 2 weeks\n* Not on anti-coagulants such as heparin, coumadin, or aspirin during study\n* No other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase risk of patient experiencing adverse events\n* Inability to give informed consent\n* Any condition which would make the patient, in the opinion of the investigator, unsuitable for the study"}, 'identificationModule': {'nctId': 'NCT00676156', 'briefTitle': 'A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'A Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'OHSU IRB00001305'}, 'secondaryIdInfos': [{'id': 'NCCAM 1K23 AT003258-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'This arm involves a 1-day pharmacokinetics study of three different formulations of oral lipoic acid.', 'interventionNames': ['Drug: oral lipoic acid (LA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'This arm will examine the pharmacokinetics of LA with and without fish oil supplement in a cross over design.', 'interventionNames': ['Drug: lipoic acid (LA) with fish oil and LA without fish oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C', 'description': 'This arm will include the study of a single dose of R enantiomer lipoic acid.', 'interventionNames': ['Drug: R lipoic acid']}], 'interventions': [{'name': 'oral lipoic acid (LA)', 'type': 'DRUG', 'description': 'A single 1200 mg dose of oral LA will be administered.', 'armGroupLabels': ['A']}, {'name': 'lipoic acid (LA) with fish oil and LA without fish oil', 'type': 'DRUG', 'description': 'Subjects will be randomized to receive either 1 dose of 1200 mg LA with fish oil and then will be crossed-over to receive 1 dose of 1200 LA without fish oil. There will be a 1-week wash out period between the cross over.', 'armGroupLabels': ['B']}, {'name': 'R lipoic acid', 'type': 'DRUG', 'description': 'A single oral dose of 1200mg R enantiomer LA will be administered.', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University Multiple Sclerosis Dept.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Vijayshree Yadav, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vijayshree Yadav', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}