Study of NXN 188 for the Treatment of Migraine With Aura
Condition: Migraine With Aura
MeSH terms: Migraine Disorders; Migraine with Aura
Intervention: NXN-188; placebo; sumatriptan succinate
Intervention description: NXN-188 hard gelatin capsules, 600 mg administered as three 200 mg capsules; administered as 3 placebo hard gelatin capsules; administered in a hard gelatin capsule with 2 capsules of placebo
Intervention MeSH terms: Sumatriptan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; aura

Summary:

      NXN-188 Dihydrochloride is being developed as an immediate release oral product for the
      treatment of acute migraine. This study is being conducted to evaluate NXN-188 in subjects
      with a migraine history of aura.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female migraineurs between 18 and 65 years old.

          2. Subjects must have a headache history of migraine with aura as defined by:

               -  Aura consisting of at least one of the following, but no muscle weakness or
                  paralysis:

                    -  Fully reversible visual symptoms

                    -  Fully reversible sensory symptoms

                    -  Fully reversible dysphasia

               -  Aura has at least two of the following characteristics:

                    -  Visual symptoms affecting only one side of the field of vision and/or
                       sensory symptoms affecting only one side of the body

                    -  At least one aura symptom that develops gradually over more than 5 minutes
                       and/or different aura symptoms occur in succession over more than 5 minutes

                    -  Each symptom lasts from 5-60 minutes

               -  Headache begins during the aura or follows aura within 60 minutes

               -  Headache not attributable to another disorder

          3. Migraine pain following aura in at least 75% of occurrences

          4. Headache frequency of at least 1 migraine attack (with or without aura) per month for
             the past 3 months but not more than 8 migraines in any 30 day period. Subjects must
             have at least 1 migraine headache with aura per month

             • Each migraine attack should last at least 4 hours (without treatment) and not longer
             than 72 hours.

          5. 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 (on a
             4-point categorical scale)

          6. Body mass index (BMI) range of 18 to 35

          7. The subject is in general good health.

             • ALT cannot be above 1.5x upper limit of normal; creatinine and urea must be within
             normal limits

          8. Speak, read, and understand English, French, or Spanish sufficiently to understand the
             nature of the study, to provide written informed consent, and complete all study
             assessments

          9. The subject is willing and able to comply with all testing requirements defined in the
             protocol

         10. All females will avoid pregnancy at least 10 days before randomization, and up until 3
             months after dosing.

         11. All subjects/partners must use a double-barrier method of birth control during the
             study and for 3 months after dosing.

        Exclusion Criteria:

          1. A diagnosis of headaches that is not consistent with migraine with aura.

          2. Presence of any risk factors that would preclude the use of triptans:

          3. Known allergy or hypersensitivity to triptans or history of any serious side effect
             with a triptan which would preclude further dosing with a triptan

          4. Presence of any clinically significant condition that would preclude study
             participation, as evaluated by the investigator

          5. Pregnancy or lactation

          6. History of significant neurological, hepatic, renal, endocrine, cardiovascular,
             gastrointestinal, pulmonary, rheumatologic, autoimmune, or metabolic disease

          7. Use of the following if taken for migraine prevention:

               -  Cardiovascular drugs (acceptable if reason for use is for treatment of
                  cardiovascular disease and the subject has been on a stable dose for 3 months)

               -  Valproate, topiramate, cyproheptadine, montelukast, or botulinum toxin.

          8. Use of monoamine oxidase inhibitors within 30 days of randomization

          9. 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)

         10. 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

         11. Participation in another drug or biologic study within 30 days of randomization into
             this study or during participation in this study

         12. Subjects who are unable or unwilling, in the opinion of the Investigator, to comply
             with all study procedures and cooperate fully with study center staff