Loading clinical trials...

A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT00530517•Zogenix, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+1 more criteria

Locations (4)

Chicago, Illinois, United States

Springfield, Missouri, United States

St Louis, Missouri, United States

Nashville, Tennessee, United States

Key Dates

Start Date

September 1, 2007

Primary Completion Date

October 1, 2007

Completion Date

October 1, 2007

Last Updated

November 10, 2022

Enrollment

ACTUAL participants

Conditions

Migraine Headache

Interventions

Intraject Sumatriptan

DEVICE

Light Exposure, Migraine Outcomes, and Sleep Quality

NCT07476053

Migraine HeadacheSleep+1 more

View study

RECRUITINGNA

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

NCT06203873

PFO - Patent Foramen OvaleMigraine+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Light Exposure, Migraine Outcomes, and Sleep Quality

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

Vitamin K2 Supplementation in Adult Episodic Migraine

Neurostimulation Device for Treatment of Migraine Headache

Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)

Efficacy, Tolerability, and Safety of DFN-15