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

NCT00530517 | Completed Phase 2 DMC

• 1 other identifier: ZX001-0701
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 4

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.

Conditions

Migraine Headache

Keywords

migraine; sumatripatan

Outcome Measures

Primary Outcomes (1)

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

  30 Days

Study Arms (1)

1

EXPERIMENTAL

Device: Intraject Sumatriptan

Interventions

Intraject Sumatriptan DEVICE

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zogenix, Inc.: lead

Study Sites (4)

Unknown Facility

Chicago, Illinois, 60614, United States

Location

Unknown Facility

Springfield, Missouri, 65807, United States

Location

Unknown Facility

St Louis, Missouri, 63141, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jan Brandes, MD

  Nashville Neuroscience Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: September 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: November 10, 2022

Record last verified: 2008-02

Locations

US (4)