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

Tracking Information

First Received Date ^ICMJE

September 13, 2007

Last Updated Date

February 7, 2008

Start Date ^ICMJE

September 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack

Change History

Complete list of historical versions of study NCT00530517 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Open Label, Active Control, Single Group Assignment

Condition ^ICMJE

Migraine Headache

Intervention ^ICMJE

Device: Intraject Sumatriptan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00530517

Responsible Party

Stephen J. Farr, Ph.D/ President and COO, Zogenix, Inc

Study ID Numbers ^ICMJE

ZX001-0701

Study Sponsor ^ICMJE

Zogenix, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jan Brandes, MD

Nashville Neuroscience Group

Information Provided By

Zogenix, Inc.

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP