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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01364259
Other study ID # SU-05252011-7806
Secondary ID
Status Recruiting
Phase Phase 3
First received May 26, 2011
Last updated June 1, 2011
Start date September 2008
Est. completion date January 2015

Study information

Verified date May 2011
Source Stanford University
Contact Lisa Jacobs
Phone (650) 723-8843
Email ljacobs@stanford.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 208
Est. completion date January 2015
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Amifostine
Amifostine and CyberKnife stereotactic radiosurgery
Procedure:
CyberKnife stereotactic radiosurgery
CyberKnife stereotactic radiosurgery

Locations

Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Facial numbness following radiosurgery Percent of patients with facial numbness following radiosurgery will be determined. 1 year No
Secondary Pain relief following radiosurgery Pain score following radiosurgery will be measured. Latency to pain relief will be assessed. 6 months No
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