Official Title: “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”

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.

Study Type: Interventional

Study Design: Other, Open Label, Active Control, Single Group Assignment

Study Primary Completion Date: October 2007

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.

Intervention(s) in this Clinical Trial

• Device: Intraject Sumatriptan
  • needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack
  • Time Frame: 30 Days
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Zogenix, Inc.

Overall Clinical Trial Officials and Contacts

Jan Brandes, MD Principal Investigator Nashville Neuroscience Group  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00530517

Study ID Number: ZX001-0701

ClinicalTrials.gov Identifier: NCT00530517

Health Authority: United States: Food and Drug Administration