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Completed

NCT Number: NCT00284505

Use of Thalidomide in Patients With Arachnoiditis

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

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Key information

Conditions

Arachnoiditis Meningitis Nervous System Diseases Neuralgia Neuroinflammatory Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington University Pain Management Center

St Louis, Missouri, 63141, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

thalidomide

Drug

Primary outcomes

  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 outcomes

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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Celgene Corporation

Registry information

Official study title

Prospective Study of the Use of Thalidomide in Patients With Arachnoiditis

Important dates

Study start
2005
Study completion
2006
First posted
Jan 31, 2006
Registry last updated
Dec 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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