A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia
This study is currently recruiting participants.
Verified May 2011 by Stanford University
Sponsor:
Stanford University
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01364259
First received: May 26, 2011
Last updated: June 1, 2011
Last verified: May 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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
Other Name: 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 |
| 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
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
No publications provided
| 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 Cranial Nerve Diseases Amifostine Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013