Clinical trial NCT00530517: A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine Headache
Keywords: migraine
sumatripatan
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-09-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Evaluate the usability of sumatriptan delivered subcutaneously via the Intraject system in adult patients during acute migraine attack
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
state: Illinois
city: Saint Louis
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Nashville Neuroscience Group
name: Jan Brandes, MD
role: PRINCIPAL_INVESTIGATOR
References: