A Study on the Usability of the Needle-Free Intraject® System in Adult Patients During Acute Migraine Attack
Information source: Zogenix, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Headache
Intervention: Intraject Sumatriptan (Device)
Phase: Phase 2
Status: Completed
Sponsored by: Zogenix, Inc. Official(s) and/or principal investigator(s):
Jan Brandes, MD, Principal Investigator, Affiliation: Nashville Neuroscience Group
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.
Clinical Details
Official title: 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
Study design: Other, Open Label, Active Control, Single Group Assignment
Primary outcome: Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Chicago, Illinois 60614, United States
Springfield, Missouri 65807, United States
St. Louis, Missouri 63141, United States
Nashville, Tennessee 37203, United States
Additional Information
Starting date: September 2007
Ending date: October 2007
Last updated: February 7, 2008
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