NCT00920686

Study of NXN 188 for the Treatment of Migraine With Aura

A Phase 2 Study of the Safety and Effectiveness of a Single Oral Dose of NXN 188 for the Treatment of Moderate to Severe Migraine Headache With Aura

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: NeurAxon Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine With Aura

Interventions

Type	Name	Description
DRUG	NXN-188	NXN-188 hard gelatin capsules, 600 mg administered as three 200 mg capsules
DRUG	placebo	administered as 3 placebo hard gelatin capsules
DRUG	sumatriptan succinate	administered in a hard gelatin capsule with 2 capsules of placebo

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-06-15
• Last updated: 2014-08-11
• Results posted: 2014-08-11

Locations

16 sites across 1 country: United States