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

Zogenix

Status and phase

Completed

Phase 2

Conditions

Migraine Headache

Treatments

Device: Intraject Sumatriptan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00530517

ZX001-0701

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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