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Use of Thalidomide in Patients With Arachnoiditis

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The Washington University

Status and phase

Completed
Phase 2

Conditions

Arachnoiditis

Treatments

Drug: thalidomide

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

3 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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