A Randomized, Placebo-controlled Trial of Amifostine for Prevention of Facial Numbness in Patients Receiving Stereotactic Radiosurgery for Trigeminal Neuralgia
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.
- drug : Amifostine
- procedure : CyberKnife stereotactic radiosurgery
Phase: Phase 3
Ages Eligible For Study:
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.