Pilot Study of Thalidomide to Treat Sjogren's Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will evaluate the safety and effectiveness of thalidomide in treating Sjogren's syndrome. In this autoimmune disease, the immune system attacks the body's tear glands and salivary glands, causing dry mouth and dry eyes. Thalidomide has shown promise in treating other autoimmune disorders, such as rheumatoid arthritis and systemic lupus erythematosus. Women with Sjogren's syndrome who have dry eyes and dry mouth may be eligible for this study. Women of childbearing potential will not be considered for participation because of severe birth defects associated with thalidomide. Also, since Sjogren's syndrome affects many fewer men than women, men are excluded from this pilot study because they would be too few in number to assess as a separate group. Candidates will be screened with a medical history, physical examination, blood and urine tests, electrocardiogram, chest X-ray and pregnancy test. Tests will also be done to measure the conduction of electrical impulses along the nerves and to evaluate dryness of the eyes. Participants will be randomly assigned to take either thalidomide or a placebo (look-alike pill with no active ingredient). The thalidomide dosage will be increased gradually from a starting dose of 50 Mg. up to 300 Mg., depending on side effects. Women of childbearing age who have had a tubal ligation or longstanding infertility will have a pregnancy test every 2 or 4 weeks. Participants will come to the clinic at the first study visit and again at weeks 4, 8 and 12 for some or all of the following procedures: * Patient assessment of dry mouth (rated on a scale from "worst ever" to "best ever" * Patient assessment of dry eyes (rated on a scale from "worst ever" to "best ever" * Patient health questionnaire and disease assessment rating * Saliva collection * Rose-Bengal or other dye tests for dryness - examination of the eyes under a bright light following administration of drops containing a dye * Schirmer's I test for dryness - placement of a thin rectangular strip of filter paper in the eye following administration of anesthetic drops * Blood tests to measure blood cell counts and levels of various immune substances in the blood, and to evaluate liver and kidney function * Urine tests to evaluate kidney function * Nerve conduction tests - measurement of the speed with which nerves conduct electrical impulses. Two nerves in the arm and one nerve in the leg will be tested. Participants will also be contacted by telephone every week to report any side effects.

About this trial record page

What this page shows

Public field values for ClinicalTrials.gov record NCT00001599, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.

What this page does not do

No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.

Where the data comes from

Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.

Last refresh

Last update posted Mar 3, 2008 · Synced Sep 3, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.