Clinical Trial: Study of the Safety and Effectiveness of NXN-188 for the Treatment of Migraine Headache Without Aura

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Without Aura

Brief 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 Summary: 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-lea
Sponsor: NeurAxon Inc.

Current Primary Outcome:

• Headache Relief (Modified LOCF - Efficacy Evaluable Analysis Set) [ Time Frame: 2 hours ]
  Headache relief at 2 hours post administration defined as reduction from Baseline moderate or severe score to mild or none.
• Headache Recurrence (Modified LOCF - Efficacy Evaluable Analysis Set) [ Time Frame: 4 hours ]
  Headache recurrence is defined as any subject that experiences headache relief at the given time point (i.e., 2 hours or 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. The denominator is the number of subjects who experienced headache relief at 2 hours/4 hours.

Original Primary Outcome: change (from baseline) in headache severity at 2 hours as recorded in the study diary [ Time Frame: 2 hours ]

Current Secondary Outcome:

• Headache Relief Based on a 2-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set) [ Time Frame: 72 hours ]
  The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain
• Headache Relief Based on a 1-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set) [ Time Frame: 72 hours ]
  The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain
• Complete Headache Relief (Efficacy Evaluable Analysis Set) [ Time Frame: 72 hours ]
• Time (Hours) to First Use of Rescue Medication (Full Analysis Set) [ Time Frame: 24 Hours ]
  Subjects who do not require rescue medication are censored at the time of their last diary assessment completed up to 24 hours following study drug administration.
• Overall Evaluation of Study Medication at 24 Hours Post Administration (Full Analysis Set) [ Time Frame: 24 hours ]
  Overall evaluation of the study drug was measured with a 4-point scale at 24 hours and used the following categories: 1 = Poor; 2 = Moderate; 3 = Good; and,4 = Excellent

Original Secondary Outcome: Headache severity score, Photophobia and Phonophobia (absent or present), Nausea, Overall Evaluation of the study medication at 24 hours,Use of any rescue medication [ Time Frame: up to 72 hours ]

Information By: NeurAxon Inc.

Dates:
Date Received: August 14, 2009
Date Started: July 2009
Date Completion:
Last Updated: July 12, 2014
Last Verified: July 2014