Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-02-25 @ 9:49 PM
Study NCT ID:
NCT02088632
Status:
TERMINATED
Last Update Posted:
2023-06-28
First Post:
2014-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Add-on Therapy Study of Xeomin (Incobotulinumtoxina) Versus Placebo in the Treatment of Trigeminal Neuralgia
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to enrolled in a timely manner.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
This is a randomized, double-blind, placebo-controlled, add-on therapy study. Up to 70 eligible subjects with medically refractory TN will be screened to enroll forty subjects; twenty will be randomized to the active medication group IncobotulinumtoxinA (Xeomin) and twenty to the placebo group (0.9% Normal Saline Solution). Using a daily diary, all subjects will document their overall pain level and attack frequency and intensity for four weeks. After the four week baseline period, subjects will undergo initial injections (IncobotulinumtoxinA \[Xeomin\] or placebo). Subjects will remain on a consistent dose of their previously prescribed medications throughout the study.
The primary outcome will be the difference in decrease in mean number of attacks of at least 4/10 intensity between the active and placebo groups. Secondary outcome measures will be frequency and average intensity of daily pain attacks. Subject Global Assessment, Beck Depression Inventory II (BDI-II), Short Form-36 (SF-36) Health Surveys, and visual analog scale (VAS), will also be assessed.
The primary outcome will be the difference in decrease in mean number of attacks of at least 4/10 intensity between the active and placebo groups. Secondary outcome measures will be frequency and average intensity of daily pain attacks. Subject Global Assessment, Beck Depression Inventory II (BDI-II), Short Form-36 (SF-36) Health Surveys, and visual analog scale (VAS), will also be assessed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: