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Prospective Study of the Use of Thalidomide in Patients With Arachnoiditis


Phase 2
18 Years
85 Years
Not Enrolling
Both
Arachnoiditis

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Trial Information

Prospective Study of the Use of Thalidomide in Patients With Arachnoiditis


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Principal Investigator

Anthony H Guarino, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University in St. Louis

Authority:

United States: Food and Drug Administration

Study ID:

CG0678

NCT ID:

NCT00284505

Start Date:

July 2005

Completion Date:

July 2006

Related Keywords:

  • Arachnoiditis
  • cytokine
  • arachnoiditis
  • neuropathic pain
  • tumor necrosis factor
  • Arachnoiditis

Name

Location
Washington University Pain Management Center St. Louis, Missouri  63141