Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Trigeminal Neuralgia
In brief
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.
Key facts
- Study ID
- NCT02088632
- Run by
- Thomas Jefferson University
- People needed
- 6
- Starts
- 2014-03-14
- Expected to finish
- 2016-10-19
- Last updated by the study team
- 2023-06-28
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Jefferson Headache Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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