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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2011 by Stanford University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Stanford University

ClinicalTrials.gov Identifier:

NCT01364259

First received: May 26, 2011

Last updated: June 1, 2011

Last verified: May 2011

History of Changes

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.

Condition	Intervention	Phase
Trigeminal Neuralgia	Drug: Amifostine Procedure: CyberKnife stereotactic radiosurgery	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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

Resource links provided by NLM:

MedlinePlus related topics: Trigeminal Neuralgia

Drug Information available for: Amifostine Amifostine monohydrate

Genetic and Rare Diseases Information Center resources: Trigeminal Neuralgia

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Facial numbness following radiosurgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Percent of patients with facial numbness following radiosurgery will be determined.

Secondary Outcome Measures:

Pain relief following radiosurgery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Pain score following radiosurgery will be measured. Latency to pain relief will be assessed.


Estimated Enrollment:	208
Study Start Date:	September 2008
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo and SRS	Procedure: CyberKnife stereotactic radiosurgery CyberKnife stereotactic radiosurgery
Experimental: Amifostine Amifostine and CyberKnife stereotactic radiosurgery	Drug: Amifostine Amifostine and CyberKnife stereotactic radiosurgery Other Name: CyberKnife stereotactic radiosurgery

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364259

Contacts


Contact: Lisa Jacobs	(650) 723-8843	ljacobs@stanford.edu

Locations


United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Lisa Jacobs 650-723-8843 ljacobs@stanford.edu
Principal Investigator: Scott Soltys
Principal Investigator: Clara Choi

Sponsors and Collaborators

Stanford University

Investigators


Principal Investigator:	Clara Choi	Stanford University
Principal Investigator:	Scott Soltys	Stanford University

More Information


Responsible Party:	Clara Choi, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT01364259 History of Changes
Other Study ID Numbers:	SU-05252011-7806
Study First Received:	May 26, 2011
Last Updated:	June 1, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Stanford University:


tic douloureux

Additional relevant MeSH terms:


Trigeminal Neuralgia 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

ClinicalTrials.gov processed this record on September 30, 2016

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