At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 195 enrolled
Drug / intervention
NXN-188 +1 moredrug
Likely dose
NXN-188 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating NXN-188 and Placebo for Migraine Without Aura. Completed, enrolled 195 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Without Aura
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedAug 2009
Primary CompletionFeb 2010
Study CompletionMar 2010
TodayJul 2026
First PostedAug 17, 2009
Enrollment StartJul 1, 2009
Primary CompletionFeb 1, 2010
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.9 years ago
Interventions
NXN-188drug
200 mg capsules, 600 mg, PRN
Placebodrug
200 mg capsules with no active ingredient designed to match the NXN-188 capsules