Study of the Safety and Effectiveness of NXN-188 for the Treatment of Migraine Headache Without Aura
Condition: Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Headache
Intervention: NXN-188; Placebo
Intervention description: 200 mg capsules, 600 mg, PRN; 200 mg capsules with no active ingredient designed to match the NXN-188 capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: migraine

Summary:

      This is a a multi-center, randomized, double-blind, parallel group, and placebo controlled,
      two-arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache
      without aura. Up to 120 migraineurs will be enrolled. Approximately 60 subjects having a
      headache history of migraine without aura will complete each of the two treatment arms to
      evaluate NXN-188 600 mg or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meets the following criteria for migraine headache without aura: Previously diagnosed
             with a history of migraine headaches; Headache has at least two (2) of the following
             characteristics: Unilateral location; Pulsating quality; Moderate or severe pain
             intensity; Aggravation by routine physical activity such as walking or climbing
             stairs; During headache, has at least one of the following characteristics: Nausea
             and/or vomiting; Photophobia and/or phonophobia;Not attributable to another disorder

          2. Headache frequency of at least 2 migraine attacks per month for the past 3 months but
             not more than 8 migraines in any 30 day period. Each migraine attack should last at
             least 4 hours (without treatment) and not longer than 72 hours.

          3. At the time of the study migraine, prior to dosing with study medication, the headache
             severity, as judged and documented by the subject, is either moderate or severe

          4. BMI within the range of 18 to 35

          5. Good general health as determined by the medical history, physical exam, clinical
             laboratory tests, vital signs and electrocardiogram. ALT cannot be above 1.5x upper
             limit of normal; creatinine and urea must be within normal limits

          6. Speak, read, and understand English or French, sufficiently to understand the nature
             of the study, to provide written informed consent, and complete all study assessments.

          7. Willing and able to comply with all testing requirements defined in the protocol

          8. Females will avoid pregnancy at least 10 days before randomization, during the study
             and up until 3 months after treatment

          9. All subjects/partners must use a double-barrier method of birth control during the
             study and for 3 months after dosing (female subjects who have had a tubal ligation > 1
             year or who are post menopausal or post hysterectomy > 1 year and male subjects who
             are surgically sterile are exempted from this inclusion criteria.

        Exclusion Criteria:

        A diagnosis of headaches that is not consistent with migraine without aura as defined in
        the inclusion criteria. Subjects with a history of migraine with aura are excluded.

          1. Presence of any risk factors that would preclude the use of triptans: Uncontrolled
             hypertension; Ischemic heart disease; Prinzmetal angina; Cardiac arrhythmias; Multiple
             risk factors for ischemic atherosclerotic vascular disease; Primary vasculopathies;
             Basilar and hemiplegic migraine

          2. Known allergy or hypersensitivity to triptans or history of any serious side effect
             with a triptan which would preclude further dosing with a triptan

          3. Presence of any clinically significant condition that would preclude study
             participation, as evaluated by the investigator

          4. Pregnant or lactating

          5. History of significant neurological, hepatic, renal, endocrine, cardiovascular,
             gastrointestinal, pulmonary, rheumatologic, autoimmune, or metabolic disease

          6. Any use (within 30 days of randomization) of migraine prevention medication including:
             Valproate (Depakote), topiramate (Topamax), cyproheptadine (Periactin), montelukast
             (Singulair), or botulinum toxin, type A (Botox); Cardiovascular drugs (acceptable if
             reason for use is for treatment of cardiovascular disease and the subject has been on
             a stable dose; MAOIs within 30 days of randomization

          7. Initiation of therapy with SSRIs or SNRIs for depression or other approved indication
             within 90 days of randomization (subjects on stable dose for >3 months for treatment
             of depression or other approved indication may be included)

          8. Are known to or suspected to be currently abusing alcohol or drugs, or have a history
             (within the past 12 months) of active alcohol or drug abuse

          9. Participation in another drug or biologic study within 30 days of randomization into
             this study or during participation in this study

         10. Subjects unable or unwilling, in the opinion of the Investigator, to comply with all
             study procedures and cooperate fully with study center staff