A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack

Study Overview
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Brief Summary
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Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan to be used by patients to treat acute migraine treatment. Study participation will last one month and include 2 doctor visits and 2-4 phone calls.

Detailed Description
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This study will evaluate how patients will interact with the needle-free Intraject system during actual self-administration to the abdomen or thigh for treatment of migraine headache while outside the clinic.

Official Title
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A Multi-Center, Open-Label, Single-dose, Single-Arm Study to Evaluate the Usability of Subcutaneously Administered Sumatriptan Delivered Via the Intraject® System in Adult Patients During Acute Migraine Attack

Conditions
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Migraine Headache

Intervention / Treatment
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* Device: Intraject Sumatriptan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of migraine with an average of ≥2 to ≤6 attacks/month Female subjects of child-bearing potential must agree to use acceptable birth control Have abdominal or thigh injection sites that have sufficient subcutaneous tissue for needle-free injection Fluent in the spoken and written English language Provide written informed consent to participate in the study and be willing to comply with the study procedures Access to a telephone for call center interactions Exclusion Criteria: A history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes including ischemic or vasospastic coronary artery disease Other significant underlying cardiovascular diseases including uncontrolled hypertension Hemiplegic or basilar migraine A history or diagnosis of severe hepatic or renal impairment A history of epilepsy or seizure or other serious neurologic condition A history of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs A history of scleroderma (systemic sclerosis) or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications Tattoos in the thigh or abdominal area that are large enough to restrict injection site selection and/or evaluation Birthmark or other significant skin discoloration in the thigh or abdominal area large enough to restrict injection site selection and/or evaluation Pregnancy or breast-feeding Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to dosing

Ages Eligible for Study
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Minimum Age: 18 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Intraject Sumatriptan<br>* needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack |  | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, sumatripatan