Trial record 1 of 2 for:    "Arachnoiditis"
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Use of Thalidomide in Patients With Arachnoiditis

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00284505
First received: January 30, 2006
Last updated: December 4, 2008
Last verified: December 2008
  Purpose

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


Condition Intervention Phase
Arachnoiditis
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 School of Medicine
  More Information

No publications provided

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

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

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

ClinicalTrials.gov processed this record on April 22, 2014