Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Zogenix, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
