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

Migraine Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530517
• Other study ID #: ZX001-0701
• Status: Completed
• Phase: Phase 2
• Start date: September 2007
• Est. completion date: October 2007

Study information

• Verified date: February 2008
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zogenix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack		30 Days