A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia
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ClinicalTrials.gov Identifier: NCT01364259 |
Recruitment Status
:
Terminated
(Patterns of practice changed and this technique is no longer used.)
First Posted
: June 2, 2011
Results First Posted
: April 4, 2017
Last Update Posted
: April 4, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Trigeminal Neuralgia | Drug: Amifostine Procedure: CyberKnife stereotactic radiosurgery | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Placebo-controlled Trial of Amifostine for Prevention of Facial Numbness in Patients Receiving Stereotactic Radiosurgery for Trigeminal Neuralgia |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo and SRS
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Procedure: CyberKnife stereotactic radiosurgery
CyberKnife stereotactic radiosurgery
|
Experimental: Amifostine
Amifostine and CyberKnife stereotactic radiosurgery
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Drug: Amifostine
Amifostine and CyberKnife stereotactic radiosurgery
Other Name: CyberKnife stereotactic radiosurgery
|
- Facial Numbness Following Radiosurgery [ Time Frame: 1 year ]Percent of patients with facial numbness following radiosurgery will be determined at one year follow up.
- Pain Relief Following Radiosurgery [ Time Frame: 1 year ]Pain improvement as assessed by the Barrow Neurological Institute (BNI) facial pain score from pre-treatment baseline of BNI 3-5 (3-some pain/controlled on medications, 4-some pain/not controlled on medications, 5-severe pain) to BNI 1-2 (1-no pain/ no medication, 2- occasional pain/no medication)

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364259
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Clara Choi | Stanford University | |
Principal Investigator: | Scott Soltys | Stanford University |
Responsible Party: | Scott Soltys, Assistant Professor, Stanford University |
ClinicalTrials.gov Identifier: | NCT01364259 History of Changes |
Other Study ID Numbers: |
IRB-14896 SU-05252011-7806 ( Other Identifier: Stanford alternate number ) |
First Posted: | June 2, 2011 Key Record Dates |
Results First Posted: | April 4, 2017 |
Last Update Posted: | April 4, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Scott Soltys, Stanford University:
tic douloureux |
Additional relevant MeSH terms:
Neuralgia Trigeminal Neuralgia Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Trigeminal Nerve Diseases |
Facial Neuralgia Facial Nerve Diseases Mouth Diseases Stomatognathic Diseases Cranial Nerve Diseases Amifostine Radiation-Protective Agents Protective Agents Physiological Effects of Drugs |