Botulinum Toxin for the Treatment of Trigeminal Neuralgia
|ClinicalTrials.gov Identifier: NCT02088632|
Recruitment Status : Terminated (Unable to enrolled in a timely manner.)
First Posted : March 17, 2014
Last Update Posted : May 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Trigeminal Neuralgia||Biological: Incobotulinumtoxina Other: Placebo Comparator||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Add-on Therapy Study of Xeomin (Incobotulinumtoxina) Versus Placebo in the Treatment of Trigeminal Neuralgia|
|Actual Study Start Date :||March 14, 2014|
|Actual Primary Completion Date :||June 11, 2015|
|Actual Study Completion Date :||October 19, 2016|
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
- Difference in mean number of attacks between active and placebo groups [ Time Frame: 84 days ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088632
|United States, Pennsylvania|
|Jefferson Headache Center at Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Stephen D Silberstein, MD||Thomas Jefferson University|