A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack. The study could take approximately 5 weeks and will include about 3 office visits to the study doctor, the patient will be contacted every 2 weeks until the patient experiences a migraine and uses the auto-injector. The last visit will be done by a telephone follow-up call.

Detailed Description
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Investigational Plan: Screening Visit [Visit 0 / 0-14 days prior to receipt of study drug] Baseline Visit [Visit 1 / Provision of study drug and subject training] Treatment Visit [Visit 2 / within 72 hours after study drug administration] Follow-up Visit [Visit 3 / Telephone follow-up 7-10 days after study drug administration]

Official Title
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A Phase 3 Open-Label Study to Assess Subcutaneous Self-Injection With Sumatriptan Succinate Using an Auto-injector During a Single Migraine Attack

Conditions
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Migraine

Intervention / Treatment
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* Drug: InvestigationalAuto-injector (sumatriptan succinate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 to 60 years of age Prior effective use of injectable sumatriptan on at least two occasions within the last two months At least two migraines per month suitable injectable sumatriptan Capable of using a migraine self-injection auto-injector Capable of distinguishing between migraine and other headache types (e.g., tension-type headache) Exclusion Criteria: Seizure disorders Coronary artery disease (CAD) Cardiac dysrhythmia or pacemaker High blood pressure Liver disease Kidney disease Autoimmune disease History of alcohol or substance abuse Currently pregnant Use of any other investigational drug product within 30 days prior to treatment visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: InvestigationalAuto-injector (sumatriptan succinate)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful administration and acceptability of self-injection of sumatriptan under the skin using an investigational auto-injector will be assessed by use of patient-completed scales and a short questionnaire. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Comparison of pain scores pre-dose and 2 hours post-dose. • Preference of investigational auto-injector experience compared to subject's previous self-administration of sumatriptan. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine