Botulinum Toxin for the Treatment of Trigeminal Neuralgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Thomas Jefferson University
Merz Pharmaceuticals, LLC
Information provided by (Responsible Party):
Thomas Jefferson University Identifier:
First received: March 4, 2014
Last updated: October 8, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Trigeminal Neuralgia
Biological: Incobotulinumtoxina
Other: Placebo Comparator
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Incobotulinumtoxina
Xeomin 25-100 units injected to chosen area one time.
Biological: Incobotulinumtoxina
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


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:Inclusion Criteria

  • Age 18 - 75 yrs
  • Male or non-pregnant/non-lactating female
  • Subjects must have a mean attack frequency of at least 3 episodes/day of 4/10 pain
  • Use of adequate birth-control measures as determined by investigator for females of child-bearing potential
  • Diagnosis of Classical trigeminal neuralgia (TN) using International Classification of Headache Disorders (ICHD-2) criteria (see Appendix A in Protocol)
  • Subjects have given written informed consent prior to entering study
  • Subjects on a stable dose of concomitant preventive medications for treatment of TN for at least 4 weeks prior to study entry and throughout the 12 week observation period
  • Subjects who require "rescue" analgesic medication during the study will be allowed to use their current (pre-study) opioid and/or non opioid analgesics as clinically indicated (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, COX-2 inhibitors, topical analgesics).
  • Subjects will be prohibited from initiating any therapy with a new preventive medication throughout the remainder of the study.
  • Subject must be willing and able to abstain from initiating an alternative therapy (e.g., acupuncture, massage or physical therapy) for pain relief during the study.

(NOTE: subjects who are currently using alternative therapy for pain relief can be enrolled if they are willing and able to maintain such therapy stable throughout the study.)

Exclusion Criteria:Exclusion Criteria

  • Symptomatic TN
  • Serious hepatic, respiratory, hematologic, cardiovascular or renal condition
  • Neurologic pain other than TN, with the exception of occasional migraine or tension-type headaches. (<4 headaches per month; < 10 headache days/month)
  • Psychiatric or medical condition that might compromise participation in study, as determined by the investigator
  • Administration of any investigational drug within 30 days prior to screening
  • History of substance abuse/alcoholism
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02088632

Contact: Kathleen Bradley, RN 215-955-2025

United States, Pennsylvania
Jefferson Headache Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kathleen Bradley, RN    215-955-2025   
Principal Investigator: Stephen D Silberstein, MD         
Sub-Investigator: Marlind Alan Stiles, DMD         
Sponsors and Collaborators
Thomas Jefferson University
Merz Pharmaceuticals, LLC
Principal Investigator: Stephen D Silberstein, MD Thomas Jefferson University
  More Information

Responsible Party: Thomas Jefferson University Identifier: NCT02088632     History of Changes
Other Study ID Numbers: XEO/SDS/01 
Study First Received: March 4, 2014
Last Updated: October 8, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Trigeminal Neuralgia
Cranial Nerve Diseases
Facial Nerve Diseases
Facial Neuralgia
Mouth Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Peripheral Nervous System Diseases
Signs and Symptoms
Stomatognathic Diseases
Trigeminal Nerve Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Cholinergic Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuromuscular Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on May 24, 2016