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Use of Thalidomide in Patients With Arachnoiditis
This study has been completed.
First Received: January 30, 2006   Last Updated: December 4, 2008   History of Changes
Sponsors and Collaborators: Washington University School of Medicine
Celgene Corporation
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00284505
  Purpose

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


Condition Intervention Phase
Arachnoiditis
Drug: thalidomide
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Prospective Study of the Use of Thalidomide in Patients With Arachnoiditis

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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.

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

Estimated Enrollment: 3
Study Start Date: July 2005
Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284505

Locations
United States, Missouri
Washington University Pain Management Center
St. Louis, Missouri, United States, 63141
Sponsors and Collaborators
Washington University School of Medicine
Celgene Corporation
Investigators
Principal Investigator: Anthony H Guarino, MD Washington University in St. Louis
  More Information

No publications provided

Study ID Numbers: CG0678
Study First Received: January 30, 2006
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00284505     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
cytokine
arachnoiditis
neuropathic pain
tumor necrosis factor

Study placed in the following topic categories:
Anti-Infective Agents
Anti-Bacterial Agents
Necrosis
Immunologic Factors
Thalidomide
Central Nervous System Infections
Central Nervous System Diseases
Pain
Arachnoiditis
Angiogenesis Inhibitors
Immunosuppressive Agents
Meningitis

Additional relevant MeSH terms:
Anti-Infective Agents
Thalidomide
Immunologic Factors
Antineoplastic Agents
Growth Substances
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Arachnoiditis
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Meningitis
Anti-Bacterial Agents
Central Nervous System Infections
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on August 30, 2009