Conditions: Migraine With Aura
Keywords: Migraine aura
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 239
Healthy volunteers: no

Brief 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.

Detailed description:
This was a multicenter, double-blind, parallel group, active and placebo-controlled, three arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache with aura.

After study eligibility was confirmed, subjects were randomized to NXN-188 600 mg, sumatriptan 100 mg, or placebo in a 1:1:1 ratio. Subjects left the clinic to self-administer the treatment at home at the onset of moderate to severe headache in a suitable dosing environment.

Treatment was not to exceed 42 days from Randomization. If the subject did not have a headache within 42 days of randomization (s)he did not take the study medication and returned it to the site. If the subject experienced a qualifying headache (s)he recorded the symptoms in a diary, dosed with the study drug, and called the IVRS to record assessments all adverse events and to report dosing. If the study drug provided insufficient relief 2 hours post dosing (s)he was permitted to use non-triptan rescue medication recommended by the investigator.

Arms:
arm 1: NXN-188, 600 mg, PRN arm 2: Sumatriptan, 100 mg, PRN arm 3: matching, PRN

Interventions: intervention 1: NXN-188 intervention 2: placebo intervention 3: sumatriptan succinate
Intervention descriptions: intervention 1: NXN-188 hard gelatin capsules, 600 mg administered as three 200 mg capsules intervention 2: administered as 3 placebo hard gelatin capsules intervention 3: administered in a hard gelatin capsule with 2 capsules of placebo

Protocol document: