NCT00284505

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

December 5, 2008

Status Verified

December 1, 2008

First QC Date

January 30, 2006

Last Update Submit

December 4, 2008

Conditions

Arachnoiditis

Keywords

cytokinearachnoiditisneuropathic paintumor necrosis factor

Outcome Measures

Primary Outcomes (2)

  • 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 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.

Interventions

thalidomideDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Radiographically confirmed Arachnoiditis
  • Involvement of the lower limb(s)

You may not qualify if:

  • Subjects with baseline peripheral neuropathy to include diabetic neuropathy and other metabolic or toxic neuropathies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University Pain Management Center

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

ArachnoiditisNeuralgia

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

MeningitisNeuroinflammatory DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Anthony H Guarino, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 30, 2006

First Posted

January 31, 2006

Study Start

July 1, 2005

Study Completion

July 1, 2006

Last Updated

December 5, 2008

Record last verified: 2008-12

Locations

US(1)