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

Phase 2

Completed

• Conditions: Migraine Headache
• Interventions: Device: Intraject Sumatriptan

• Registration Number: NCT00530517
• Lead Sponsor: Zogenix, Inc.

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-13
• Study First Submitted QC: 2007-09-13
• Study First Posted: 2007-09-17
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-02
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Intraject Sumatriptan	-

Primary Outcome Measures

Name	Time	Method
Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack	30 Days