Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Thalidomide in Patients With Arachnoiditis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00284505
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : December 5, 2008
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Washington University School of Medicine

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This pilot study will evaluate whether thalidomide decreases pain in patients with arachnoiditis.

Condition or disease Intervention/treatment Phase
Arachnoiditis Drug: thalidomide Phase 2

Detailed Description:
Arachnoiditis, a neuropathic disease caused by inflamation of the arachnoid membrane that surrounds and protects the spinal nerves,can result in a debilitating state that is characterized by numbing and tingling, stinging and burning in the lower back or legs, and possible muscle cramps, twitching and spasms. Current treatments are not always effective in treating the pain associated with arachnoiditis. Recent research has indicated that a group of chemicals called cytokines that are produced by various cells in the body may be responsible for generating the pain response. Medications that effect the release of cytokines or block the action of cytokines may reduce the pain response. Various anti-cytokine medications are now being used to treat painful disease states such as rheumotoid arthritis and Crohn's Disease. In this study the anti-cytokine medication, Thalidomide, is being evaluated for it's effect in treating pain associated with arachnoiditis.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of the Use of Thalidomide in Patients With Arachnoiditis
Study Start Date : July 2005
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Thalidomide

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 1. To evaluate the change in pain as measured by the McGill Pain Questionnaire, short form, (SF-MPQ) and consumption of adjuvant opioid medications in three patients with arachnoiditis who receive thalidomide.
  2. 2. To evaluate the change in physical functionality as measured by the Roland-Morris Low Back Pain and Disability Questionnaire in three patients with arachnoiditis who receive thalidomide.

Secondary Outcome Measures :
  1. 1. To measure change in the patient's health status as measured by the SF36 in three patients with arachnoiditis who receive thalidomide.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Radiographically confirmed Arachnoiditis
  • Involvement of the lower limb(s)

Exclusion Criteria:

  • Subjects with baseline peripheral neuropathy to include diabetic neuropathy and other metabolic or toxic neuropathies.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284505


Locations
Layout table for location information
United States, Missouri
Washington University Pain Management Center
St. Louis, Missouri, United States, 63141
Sponsors and Collaborators
Washington University School of Medicine
Celgene Corporation
Investigators
Layout table for investigator information
Principal Investigator: Anthony H Guarino, MD Washington University School of Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00284505    
Other Study ID Numbers: CG0678
First Posted: January 31, 2006    Key Record Dates
Last Update Posted: December 5, 2008
Last Verified: December 2008
Keywords provided by Washington University School of Medicine:
cytokine
arachnoiditis
neuropathic pain
tumor necrosis factor
Additional relevant MeSH terms:
Layout table for MeSH terms
Arachnoiditis
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents