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A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia
Not Recruiting
Trial ID: NCT01364259,27502,17516
Purpose
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.
Official Title
A Randomized, Placebo-controlled Trial of Amifostine for Prevention of Facial Numbness in Patients Receiving Stereotactic Radiosurgery for Trigeminal Neuralgia
Stanford Investigator(s)
Scott G. Soltys, MD
Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery
Eligibility
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.
Intervention(s):
drug: Amifostine
procedure: CyberKnife stereotactic radiosurgery
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Lisa Jacobs
650-723-8843