Naratriptan for the Treatment of Post Traumatic Headache Associated With Cognitive Dysfunction
Condition: Post Traumatic Headache
MeSH terms: Post-Traumatic Headache; Headache; Cognitive Dysfunction
Intervention: naratriptan HCl
Intervention description: naratriptan 2.5mg tablet bid x 30 days OR matching placebo
Intervention MeSH terms: Naratriptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Post traumatic headache; Head trauma; Head injury; Headache; Naratriptan

Summary:

      The purpose of this study is to determine whether naratriptan, a medication approved for
      treatment of migraine, is effective in the treatment of post traumatic headache associated
      with cognitive dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between the ages of 18-55. A female is eligible to enter and
             participate if she is of: non-childbearing potential (i.e., physiologically incapable
             of becoming pregnant); or, child-bearing potential, has a negative pregnancy test
             (urine or serum) at screen, and agrees to one of the following: Complete abstinence
             from intercourse from 2 weeks prior to administration of the investigational product,
             throughout the study, and for a time interval (5 days) after completion or premature
             discontinuation from the study; subjects utilizing this method must agree to use
             alternate method of contraception if they become sexually active and will be queried
             on whether they have been abstinent when they present to the clinic for the Final
             Visit or, Female sterilization; or, Sterilization of male partner; or, Implants of
             levonorgestrel; or, Injectable progestogen; or, Oral contraceptive (combined or
             progestogen only); or, Any intrauterine device (IUD) with published data showing
             highest expected failure rate is less than 1% per year (not all IUDs meet this
             criterion); or, Spermicide plus a mechanical barrier (e.g., spermicide plus a male
             condom or a female diaphragm). Any other barrier methods (only if used in combination
             with any of the above acceptable methods) or, Any other methods with published data
             showing highest expected failure rate for that method is less than 1% per year.

          -  Formally diagnosed ICHD 5.2.2 chronic post traumatic headache

          -  Have had traumatic brain injury (TBI) not more than 5 years prior to enrollment

          -  Medically stable as determined by Investigator

          -  On stabilized dosage of any headache preventive medications for 3 months prior to
             screening

          -  On stabilized dosage of concomitant medications at discretion of investigator

          -  Chronic headache history only after the TBI

          -  Able to understand and communicate intelligibly with study observer

          -  Able to take oral medication, adhere to the medication regimens and perform study
             procedures

          -  Able to read and comprehend written instructions and be willing to complete all
             procedures and assessments required by protocol

          -  Subject is able to demonstrate willingness to participate by signing and understanding
             an informed consent after full explanation of study

          -  Self-reported cognitive inefficiency or "brain-fog" during headache

        Exclusion Criteria:

          -  History of hypersensitivity to triptan-like medication

          -  Pathology of salivary glands such as sialadenitis (e.g., Sjorgen's Syndrome, viral or
             bacterial sialadenitis, or obstructive sialadenitis)

          -  Any condition or symptom that would knowingly alter content of saliva

          -  History of, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral
             vascular syndromes or other significant underlying cardiovascular disease. Ischemic
             cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g.
             stable angina of effort and vasospastic forms of angina such as Prinzmetal variant,
             all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular
             syndromes include, but are not limited to, strokes of any type as well as transient
             ischemic attacks. Peripheral vascular disease includes, but is not limited to,
             ischemic bowel disease.

          -  Any medication overuse that in the opinion of the investigator has exacerbated or
             contributed to current headache pattern of subject

          -  Uncontrolled hypertension, severe renal impairment, severe hepatic impairment,
             hemiplegic or basilar headache

          -  History of hypersensitivity to naratriptan or any components

          -  Pregnant, trying to get pregnant, or lactating

          -  Recent history of abuse of alcohol or other drugs that would interfere with
             participation

          -  Participation in another investigative drug study within previous 30 days

          -  Chronic pain syndromes, fibromyalgia, Gulf War Syndrome, and other multisystem
             diseases characterized by poor or no response to pain-reducing interventions