Botulinum Toxin for the Treatment of Trigeminal Neuralgia
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|