A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has been shown to provide pain relief in majority of patients treated. However, a common side effect of radiosurgery is facial numbness. Our goal is to maximize pain control while minimizing side effects. To this end, the purpose of this study is to evaluate whether adding a drug, amifostine, at the time of radiosurgery will protect patients from facial numbness.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Amifostine

Criteria

Inclusion Criteria:

All patients age 18 years and older with typical trigeminal neuralgia, as determined by diagnostic criteria set by the International Headache Society, who are:

• Intolerant of or refractory to medical management; AND

• Not candidates for or refusing a surgical micro-vascular decompression.

Exclusion Criteria:

• Patients who present with pre-existing BNI grade III or IV facial numbness.

• Patients who have previously been treated with MVD.

• Patients who have previously had an ablative treatment, including prior SRS.

• Pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent will be excluded.