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Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia

NCT02088632 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-06-28

Study results available
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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.

Conditions

  • Trigeminal Neuralgia

Interventions

BIOLOGICAL

Incobotulinumtoxina

Incobotulinumtoxina (Xeomin) is botulinum toxin type A and is administered via intramuscular injection.

OTHER

Placebo Comparator

Normal saline is sterile sodium chloride without and preservatives.

Sponsors & Collaborators

  • Merz North America, Inc.

    collaborator INDUSTRY

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Stephen D Silberstein, MD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-14
Primary Completion
2015-06-11
Completion
2016-10-19

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02088632 on ClinicalTrials.gov