Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2026-02-20 @ 5:57 PM
Study NCT ID:
NCT00001918
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
L-5-HTP-Related EMS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016603', 'term': 'Eosinophilia-Myalgia Syndrome'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D008569', 'term': 'Memory Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1999-06', 'completionDateStruct': {'date': '2000-08'}, 'lastUpdateSubmitDate': '2008-03-03', 'studyFirstSubmitDate': '1999-11-03', 'studyFirstSubmitQcDate': '2002-12-09', 'lastUpdatePostDateStruct': {'date': '2008-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-12-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Cognitive Function', 'Depression', 'EMG', 'Eosinophilia Myalgia Syndrome', 'Impurities', 'L-5-HTP', 'Memory Impairment', 'Nerve-Muscle Biopsy', 'Sleep Disorders'], 'conditions': ['Eosinophilia-Myalgia Syndrome']}, 'referencesModule': {'references': [{'pmid': '1690352', 'type': 'BACKGROUND', 'citation': 'Silver RM, Heyes MP, Maize JC, Quearry B, Vionnet-Fuasset M, Sternberg EM. Scleroderma, fasciitis, and eosinophilia associated with the ingestion of tryptophan. N Engl J Med. 1990 Mar 29;322(13):874-81. doi: 10.1056/NEJM199003293221302.'}, {'pmid': '1727200', 'type': 'BACKGROUND', 'citation': 'Kamb ML, Murphy JJ, Jones JL, Caston JC, Nederlof K, Horney LF, Swygert LA, Falk H, Kilbourne EM. Eosinophilia-myalgia syndrome in L-tryptophan-exposed patients. JAMA. 1992 Jan 1;267(1):77-82. doi: 10.1001/jama.267.1.77.'}, {'pmid': '1969024', 'type': 'BACKGROUND', 'citation': 'Eidson M, Philen RM, Sewell CM, Voorhees R, Kilbourne EM. L-tryptophan and eosinophilia-myalgia syndrome in New Mexico. Lancet. 1990 Mar 17;335(8690):645-8. doi: 10.1016/0140-6736(90)90421-z.'}]}, 'descriptionModule': {'briefSummary': "In 1989 more than 1500 people who took the dietary supplement L-tryptophan for insomnia and depression developed eosinophilia myalgia syndrome (EMS)-a potentially fatal disease characterized by an excess of a type of white blood cell called eosinophils. Disease symptoms include fever, muscle aches and inflammation, and skin rashes. As many as 40 of the patients who became ill died. It is suspected that impurities in the supplements caused the disease. More recently, similar impurities have been detected in batches of a similar dietary supplement called L-5-hydroxytryptophan.\n\nThis study is designed to learn more about EMS that develops in patients taking L-5-hydroxytryptophan. The study is open to patients newly diagnosed with eosinophilia myalgia who have taken L-5-HTP. Patients in the study will have a physical examination and urine and blood tests. They may also have X rays, an electrocardiogram, magnetic resonance imaging (MRI), and a skin test for tuberculosis. They will have a psychiatric interview, take a memory test, and fill out questionnaires relating to sadness and depression.\n\nPatients may also undergo special tests to study conduction of nerve impulses and muscle function.\n\nSamples of patients' supplements will be taken for chemical analysis.", 'detailedDescription': 'The L-tryptophan-related eosinophilia myalgia syndrome (EMS), characterized by eosinophilia, myalgias, myositis, scleroderma-like skin fibrosis and fasciitis, occurred in 1989 in over 1500 patients who had ingested L-tryptophan for sleep disturbances and depression. The identical clinical syndrome has also occurred in subjects ingesting L-5-hydroxytryptophan (L-5-HTP).\n\nRecently, a letter to Nature Medicine reported the presence of an impurity in 6 out of 6 samples of L-5-HTP obtained randomly at health food stores. This impurity appears to be the same as the one identified in material ingested by a family (mother and 2 babies) who had developed an EMS-like syndrome after ingesting L-5-HTP.\n\nAlthough there have been no definite new cases of L-5-HTP-related EMS, the FDA is currently investigating unconfirmed reports of possible new cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients must be at least 18 years of age.\n\nPatients newly diagnosed with eosinophilia and myalgia, and who ingested L-5-HTP.\n\nSubjects will be defined as having 5-L-HTP related EMS according to the diagnostic criteria originally established by the CDC for diagnosis of L-tyrptophan-related EMS.'}, 'identificationModule': {'nctId': 'NCT00001918', 'briefTitle': 'L-5-HTP-Related EMS', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'L-5-Hydroxy-Tryptophan-Related Eosinophilia-Myalgia Syndrome (EMS): Clinical Patient Evaluation', 'orgStudyIdInfo': {'id': '990136'}, 'secondaryIdInfos': [{'id': '99-M-0136'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institute of Mental Health (NIMH)', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}}}}