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Botulinum Toxin for the Treatment of Trigeminal Neuralgia

This study has been terminated.
(Unable to enrolled in a timely manner.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02088632
First Posted: March 17, 2014
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merz North America, Inc.
Information provided by (Responsible Party):
Thomas Jefferson University
  Purpose
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: Triple (Participant, Care Provider, 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 ]
    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 ]
    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.


Enrollment: 8
Actual Study Start Date: March 14, 2014
Study Completion Date: October 19, 2016
Primary Completion Date: June 11, 2015 (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

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


Locations
United States, Pennsylvania
Jefferson Headache Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Merz North America, Inc.
Investigators
Principal Investigator: Stephen D Silberstein, MD Thomas Jefferson University
  More Information

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02088632     History of Changes
Other Study ID Numbers: XEO/SDS/01
First Submitted: March 4, 2014
First Posted: March 17, 2014
Last Update Posted: May 23, 2017
Last Verified: May 2017

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