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

November 8, 2022 updated by: Zogenix, Inc.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60614
    • Missouri
      • Saint Louis, Missouri, United States, 63141
      • Springfield, Missouri, United States, 65807
    • Tennessee
      • Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6mg Sumatriptan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack
Time Frame: 30 Days
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Jan Brandes, MD, Nashville Neuroscience Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

September 13, 2007

First Submitted That Met QC Criteria

September 13, 2007

First Posted (Estimate)

September 17, 2007

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

February 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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