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Pilot Study of Thalidomide to Treat Sjogren's Syndrome

NCT00001599 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2008-03-04

No results posted yet for this study

Summary

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.

Conditions

  • Sjogren's Syndrome
  • Xerostomia

Interventions

DRUG

Thalidomide

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-05-31
Completion
2002-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00001599 on ClinicalTrials.gov