Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia
Condition: Trigeminal Neuralgia
MeSH terms: Trigeminal Neuralgia; Neuralgia
Intervention: Incobotulinumtoxina; Placebo Comparator
Intervention description: Incobotulinumtoxina (Xeomin) is botulinum toxin type A and is administered via intramuscular injection.; Normal saline is sterile sodium chloride without and preservatives.
Intervention MeSH terms: incobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility 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,
             cyclooxygenase-2 (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