NCT00530517

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Zogenix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine Headache

Interventions

Type	Name	Description
DEVICE	Intraject Sumatriptan	needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan

Timeline

• Start date: 2007-09-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2007-09-17
• Last updated: 2022-11-10

Locations

4 sites across 1 country: United States