Use of Thalidomide in Patients With Arachnoiditis

• ClinicalTrials.gov Identifier: NCT00284505
• Recruitment Status: Completed
• First Posted: January 31, 2006
• Last Update Posted: December 5, 2008
• Sponsor: Washington University School of Medicine
• Collaborator: Celgene Corporation
• Information provided by: Washington University School of Medicine

Tracking Information

• First Submitted Date: January 30, 2006
• First Posted Date: January 31, 2006
• Last Update Posted Date: December 5, 2008
• Study Start Date: July 2005
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: January 30, 2006)

• 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. 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 30, 2006): 1. To measure change in the patient's health status as measured by the SF36 in three patients with arachnoiditis who receive thalidomide.
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Use of Thalidomide in Patients With Arachnoiditis
• Official Title: Prospective Study of the Use of Thalidomide in Patients With Arachnoiditis
• Brief Summary: This pilot study will evaluate whether thalidomide decreases pain in patients with arachnoiditis.
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Arachnoiditis
• Intervention: Drug: thalidomide
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: January 30, 2006): 3
• Original Enrollment: Same as current
• Actual Study Completion Date: July 2006
• Primary Completion Date: Not Provided

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00284505
• Other Study ID Numbers: CG0678
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Washington University School of Medicine
• Collaborators: Celgene Corporation

Investigators

• Principal Investigator: Anthony H Guarino, MD; Washington University School of Medicine

• PRS Account: Washington University School of Medicine
• Verification Date: December 2008