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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      After study eligibility was confirmed and all screening procedures completed, subjects were
      randomized at Visit 1 to receive either NXN-188 600 mg or placebo in a 1:1 ratio. Study drug
      and diaries were dispensed, and subjects were instructed regarding when to dose with study
      drug. Subjects were also trained regarding the Interactive Voice Response System (IVRS), and
      made familiar with the study diary and the completion of study diary assessments. Subjects
      left the clinic to self-administer treatment as an outpatient at the onset of a moderate to
      severe migraine headache without aura (as rated on a 4-point categorical scale). Dosing with
      study drug was to take place within 42 days from Randomization (Visit 1). The subject
      contacted the investigatorI or designee at 14 and 28 days after Randomization if they had not
      yet treated a migraine headache without aura in order to receive verbal permission from the
      site personnel to continue in the study as appropriate. If the subject had not treated a
      migraine headache within 42 days of Visit 1, the subject did not take study drug and returned
      all materials, including the unused study drug, to the study site. If the subject experienced
      a qualifying migraine without aura during the treatment period, (s)he recorded headache
      symptoms in the study diary when first noticed (and menstrual cycle status [female subjects
      only]). If the subject met dosing requirements as outlined in the protocol, they dosed with
      the study drug, called the IVRS to report dosing, recorded all assessments and adverse events
      (AEs) and contacted the study center to schedule a post treatment visit (Visit 2) within 6
      days (± 2 days) of treatment. If study drug resulted in insufficient relief at 2 hours p.a.,
      subjects were permitted to use the non-triptan rescue medication recommended by the PI at
      Visit 1. Within 6 days (± 2 days) of treatment, the subject returned to the study center for
      Visit 2. The subject had a brief physical examination, a 12-lead electrocardiogram (ECG), and
      had samples taken for clinical laboratory tests, including a serum pregnancy test for all
      females. Concomitant medications taken and adverse events (AEs) experienced from time of
      dosing to Visit 2 were reported to site personnel and recorded. Study diaries were reviewed
      and information recorded. Discontinuing subjects returned unused study drug and study
      material. One safety follow-up telephone contact was made within 15 days (± 2 days) post
      treatment. For those subjects not meeting the Treatment/Enrollment criteria by Day 42 (i.e.,
      not experiencing a qualifying headache) and for other subjects discontinuing the study
      protocol post Randomization (Visit 1), a second visit, Visit 2, was required and subjects
      underwent a brief physical examination, had vital signs and ECGs performed, samples collected
      for clinical labs, concomitant medications and AEs reviewed, and returned all study drug and
      study materials.
    

Intervention name(s): NXN-188; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg capsules, 600 mg, PRN; 200 mg capsules with no active ingredient designed to match the NXN-188 capsules
Other intervention name(s): NXN-188 dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: migraine