Botulinum Toxin for the Treatment of Trigeminal Neuralgia
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 6/15/2016 |
| Start Date: | March 2014 |
| End Date: | December 2017 |
| Contact: | Kathleen Bradley, RN |
| Email: | kathleen.bradley@jefferson.edu |
| Phone: | 215-955-2025 |
A Randomized, Double-Blind, Placebo-Controlled, Add-on Therapy Study of Xeomin (Incobotulinumtoxina) Versus Placebo in the Treatment of Trigeminal Neuralgia
IncobotulinumtoxinA (Xeomin®) is a neurotoxin which inhibits the release of certain
chemicals at the nerve terminals. It blocks cholinergic transmission at the neuromuscular
junction by inhibiting the release of acetylcholine from motor neurons. In addition it
blocks the release of Substance P (SP) and Calcitonin Gene Related Peptide (CGRP) from C
fibers involved in pain perception. This study is designed to see if Xeomin® is superior to
placebo in the treatment of medically refractory trigeminal neuralgia (TN). Subjects will be
asked to maintain an attack diary throughout the study. They will also be asked to attend 4
office visits; Visit 1- Screening Visit, Visit 2- Injection Visit, Visit 3- Follow-Up Visit
and Visit 4- Final Visit. At the end of the study the active (Xeomin®) and placebo groups
will be compared to see if one group had better relief than the other.
chemicals at the nerve terminals. It blocks cholinergic transmission at the neuromuscular
junction by inhibiting the release of acetylcholine from motor neurons. In addition it
blocks the release of Substance P (SP) and Calcitonin Gene Related Peptide (CGRP) from C
fibers involved in pain perception. This study is designed to see if Xeomin® is superior to
placebo in the treatment of medically refractory trigeminal neuralgia (TN). Subjects will be
asked to maintain an attack diary throughout the study. They will also be asked to attend 4
office visits; Visit 1- Screening Visit, Visit 2- Injection Visit, Visit 3- Follow-Up Visit
and Visit 4- Final Visit. At the end of the study the active (Xeomin®) and placebo groups
will be compared to see if one group had better relief than the other.
Inclusion Criteria:Inclusion Criteria
- Age 18 - 75 yrs
- Male or non-pregnant/non-lactating female
- Subjects must have a mean attack frequency of at least 3 episodes/day of 4/10 pain
- Use of adequate birth-control measures as determined by investigator for females of
child-bearing potential
- Diagnosis of Classical trigeminal neuralgia (TN) using International Classification
of Headache Disorders (ICHD-2) criteria (see Appendix A in Protocol)
- Subjects have given written informed consent prior to entering study
- Subjects on a stable dose of concomitant preventive medications for treatment of TN
for at least 4 weeks prior to study entry and throughout the 12 week observation
period
- Subjects who require "rescue" analgesic medication during the study will be allowed
to use their current (pre-study) opioid and/or non opioid analgesics as clinically
indicated (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, COX-2
inhibitors, topical analgesics).
- Subjects will be prohibited from initiating any therapy with a new preventive
medication throughout the remainder of the study.
- Subject must be willing and able to abstain from initiating an alternative therapy
(e.g., acupuncture, massage or physical therapy) for pain relief during the study.
(NOTE: subjects who are currently using alternative therapy for pain relief can be
enrolled if they are willing and able to maintain such therapy stable throughout the
study.)
Exclusion Criteria:Exclusion Criteria
- Symptomatic TN
- Serious hepatic, respiratory, hematologic, cardiovascular or renal condition
- Neurologic pain other than TN, with the exception of occasional migraine or
tension-type headaches. (<4 headaches per month; < 10 headache days/month)
- Psychiatric or medical condition that might compromise participation in study, as
determined by the investigator
- Administration of any investigational drug within 30 days prior to screening
- History of substance abuse/alcoholism
We found this trial at
1
site
Philadelphia, Pennsylvania 19107
Principal Investigator: Stephen D Silberstein, MD
Phone: 215-955-2025
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