Clinical Trial: Study of NXN 188 for the Treatment of Migraine With Aura
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
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 Summary:
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.
Sponsor: NeurAxon Inc.
Current Primary Outcome: Time (Hours) to First Use of Rescue Medication [ Time Frame: 24 hours ]
Original Primary Outcome: The primary efficacy assessment will be the time to rescue medication usage. [ Time Frame: 24 hours ]
Current Secondary Outcome:
- Headache Relief and Recurrence (Observed Cases) [ Time Frame: 2, 4 and up to 24 hours ]
Headache relief is defined as a ≥ 1-point reduction from baseline in Headache Severity Score. The Headache Severity Score is a four-point scale: 0=no pain; 1 = mild pain; 2 = moderate pain; and 3 = severe pain.
Headache recurrence is defined as any subject that experiences headache relief within 4 hours, who did not use rescue medication, and who experienced a worsening of their headache to moderate or severe within 24 hours following study drug administration.
- 2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea [ Time Frame: 2 hours ]
Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.
Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present
Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea
- 4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea [ Time Frame: 4 hours ]
Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.
Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present
Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea
- 24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea [ Time Frame: 24 hours ]
Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.
Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present
Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea
Original Secondary Outcome:
- Headache severity score [ Time Frame: 72 hours ]
- Photophobia and Phonophobia [ Time Frame: 72 hours ]
- Nausea [ Time Frame: 72 hours ]
Information By: NeurAxon Inc.
Dates:
Date Received: June 12, 2009
Date Started: June 2009
Date Completion:
Last Updated: July 20, 2014
Last Verified: July 2014
