Botulinum Toxin for the Treatment of Trigeminal Neuralgia

• ClinicalTrials.gov Identifier: NCT02088632
• Recruitment Status: Terminated
• First Posted: March 17, 2014
• Last Update Posted: May 23, 2017
• Sponsor: Thomas Jefferson University
• Collaborator: Merz North America, Inc.
• Information provided by (Responsible Party): Thomas Jefferson University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Trigeminal Neuralgia	Biological: Incobotulinumtoxina; Other: Placebo Comparator	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• 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
• Actual Study Start Date: March 14, 2014
• Actual Primary Completion Date: June 11, 2015
• Actual Study Completion Date: October 19, 2016

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• 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.)

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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

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
• Other Study ID Numbers: XEO/SDS/01
• First Posted: March 17, 2014
• Last Update Posted: May 23, 2017
• Last Verified: May 2017

Additional relevant MeSH terms:

Trigeminal Neuralgia; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; incobotulinumtoxinA; Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents