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NCT01364259 · ClinicalTrials.gov registry record · Phase 3
A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia
A Phase 3 study, sponsored by Stanford University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 17
- Enrollment target
NCT01364259: Clinical Trial Phase 3 study, sponsored by Stanford University.
NCT01364259 is a Phase 3 study that was terminated before completion, run by Stanford University. The registered enrollment target is 17 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01364259, a Phase 3 study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
Percent of patients with facial numbness following radiosurgery will be determined at one year follow up.
Interventions
- DRUG Amifostine
- PROCEDURE CyberKnife stereotactic radiosurgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2008-09 |
| Est. Completion | 2015-01 |
| Phase | Phase 3 |
Why NCT01364259 stopped before completion
NCT01364259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Amifostine is the first listed.
NCT01364259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01364259 about?
NCT01364259 is a clinical study titled "A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia". 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 fac...
What is the current status of trial NCT01364259?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 17 participants. The study started on 2008-09. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01364259?
The interventions under investigation include: Amifostine (DRUG), CyberKnife stereotactic radiosurgery (PROCEDURE).
Who is sponsoring clinical trial NCT01364259?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01364259's enrollment target sits among peer trials
17 1971st of 2000 higher than 27 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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