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

NCT01364259 | Terminated Phase 3 Results DMC

• 2 other identifiers: IRB-14896SU-05252011-7806
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trigeminal Neuralgia

Keywords

tic douloureux

Outcome Measures

Primary Outcomes (1)

• Facial Numbness Following Radiosurgery

  Percent of patients with facial numbness following radiosurgery will be determined at one year follow up.

  1 year

Secondary Outcomes (1)

• Pain Relief Following Radiosurgery

  1 year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo and SRS

Procedure: CyberKnife stereotactic radiosurgery

Amifostine

EXPERIMENTAL

Amifostine and CyberKnife stereotactic radiosurgery

Drug: Amifostine

Interventions

Amifostine DRUG

Amifostine and CyberKnife stereotactic radiosurgery

Also known as: CyberKnife stereotactic radiosurgery

Amifostine

CyberKnife stereotactic radiosurgery PROCEDURE

CyberKnife stereotactic radiosurgery

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Amifostine; Radiosurgery

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Scott G. Soltys, Assistant Professor
• Organization: Stanford University Cancer Center

sgsoltys@stanford.edu

650.724.1569

Study Officials

• Clara Choi

  Stanford University

  PRINCIPAL INVESTIGATOR

• Scott Soltys

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: June 2, 2011
• Study Start: September 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)