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L-5-HTP-related EMS Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about L-5-HTP-related EMS conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. L-5-HTP-related EMS Clinical research trials and L-5-HTP-related EMS health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including L-5-HTP-related EMS. L-5-HTP-related EMS Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a L-5-HTP-related EMS clinical trial. Human subjects often get the best healthcare possible for their L-5-HTP-related EMS condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "L" Clinical Trials Conditions > L-5-HTP-related EMS  L-5-HTP-related EMS
L-5-HTP-related EMS
For Condition: Eosinophilia-Myalgia Syndrome
Status: Completed
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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. This 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. Patients may also undergo special tests to study conduction of nerve impulses and muscle function. Samples of patients' supplements will be taken for chemical analysis.
Details: 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). Recently, 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. Although there have been no definite new cases of L-5-HTP-related EMS, the FDA is currently investigating unconfirmed reports of possible new cases.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients must be at least 18 years of age. Patients newly diagnosed with eosinophilia and myalgia, and who ingested L-5-HTP. Subjects 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.
Total Enrollment: 20
Location and Contact Information:
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990136; 99-M-0136
Study Start Date: July 8, 1999
Record last reviewed: June 15, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001918
Other Eosinophilia-Myalgia Syndrome Studies:
1. L-5-HTP-related EMS
Related Studies:
Other Eosinophilia-Myalgia Syndrome Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
L-5-HTP-related EMS
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