Use of Thalidomide in Patients With Arachnoiditis

Arachnoiditis Clinical Trial

Official title:

Prospective Study of the Use of Thalidomide in Patients With Arachnoiditis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284505
• Other study ID #: CG0678
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2006
• Last updated: December 4, 2008
• Start date: July 2005
• Est. completion date: July 2006

Study information

• Verified date: December 2008
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This pilot study will evaluate whether thalidomide decreases pain in patients with arachnoiditis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arachnoiditis

Intervention

Drug:
• thalidomide

Locations

Country	Name	City	State
United States	Washington University Pain Management Center	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	1. To measure change in the patient's health status as measured by the SF36 in three patients with arachnoiditis who receive thalidomide.