Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT02088632
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.)
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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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02088632
Study Brief:
Protocol Section:
NCT02088632