Migraine Headache
Conditions
Keywords
migraine, sumatripatan
Brief summary
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
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.
Interventions
DEVICEIntraject Sumatriptan
needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan
Sponsors
Zogenix, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack | 30 Days |
Countries
United States
Outcome results
None listed