Botulinum Toxin for 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.
Other: Placebo Comparator
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Add-on Therapy Study of Xeomin (Incobotulinumtoxina) Versus Placebo in the Treatment of Trigeminal Neuralgia|
- Difference in mean number of attacks between active and placebo groups [ Time Frame: 84 days ] [ Designated as safety issue: No ]Patient evaluated at day 84. Mean daily number of attacks during baseline period (30days) will be compared to mean daily number of attacks for days 1-84 as recorded in patient diary.
- Difference in mean intensity between placebo and control groups [ Time Frame: 84 days ] [ Designated as safety issue: No ]Patient evaluated at day 84. Mean daily intensity during baseline period (30days) will be compared to mean daily intensity for days 1-84 as recorded in patient diary.
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Incobotulinumtoxina
Xeomin 25-100 units injected to chosen area one time.
Incobotulinumtoxina (Xeomin) is botulinum toxin type A and is administered via intramuscular injection.
Other Name: Xeomin
Placebo Comparator: Placebo Comparator
Placebo Comparator is 1-2 ml normal saline solution injected to chosen area one time.
Other: Placebo Comparator
Normal saline is sterile sodium chloride without and preservatives.
Other Name: Normal Saline, sodium chloride, placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT02088632
|Contact: Kathleen Bradley, RNfirstname.lastname@example.org|
|United States, Pennsylvania|
|Jefferson Headache Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Kathleen Bradley, RN 215-955-2025 email@example.com|
|Principal Investigator: Stephen D Silberstein, MD|
|Sub-Investigator: Marlind Alan Stiles, DMD|
|Principal Investigator:||Stephen D Silberstein, MD||Thomas Jefferson University|