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

NCT ID: NCT00530517

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2007-10-31

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.

Conditions

Migraine Headache

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Intraject Sumatriptan

Intervention Type: DEVICE

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

Interventions

Intraject Sumatriptan

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zogenix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Zogenix, Inc

Principal Investigators

Jan Brandes, MD

Role: PRINCIPAL_INVESTIGATOR

Nashville Neuroscience Group

Locations

Chicago, Illinois, United States

Springfield, Missouri, United States

St Louis, Missouri, United States

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

ZX001-0701

Identifier Type: -

Identifier Source: org_study_id