Clinical trial NCT00510419: A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack
Official title: A Phase 3 Open-Label Study to Assess Subcutaneous Self-Injection With Sumatriptan Succinate Using an Auto-injector During a Single Migraine Attack
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-08-02
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack.

The study could take approximately 5 weeks and will include about 3 office visits to the study doctor, the patient will be contacted every 2 weeks until the patient experiences a migraine and uses the auto-injector. The last visit will be done by a telephone follow-up call.

Detailed description: Investigational Plan:

1. Screening Visit \[Visit 0 / 0-14 days prior to receipt of study drug\]
2. Baseline Visit \[Visit 1 / Provision of study drug and subject training\]
3. Treatment Visit \[Visit 2 / within 72 hours after study drug administration\]
4. Follow-up Visit \[Visit 3 / Telephone follow-up 7-10 days after study drug administration\]

Eligibility criteria: Inclusion Criteria:

1. Adults 18 to 60 years of age
2. Prior effective use of injectable sumatriptan on at least two occasions within the last two months
3. At least two migraines per month suitable injectable sumatriptan
4. Capable of using a migraine self-injection auto-injector
5. Capable of distinguishing between migraine and other headache types (e.g., tension-type headache)

Exclusion Criteria:

1. Seizure disorders
2. Coronary artery disease (CAD)
3. Cardiac dysrhythmia or pacemaker
4. High blood pressure
5. Liver disease
6. Kidney disease
7. Autoimmune disease
8. History of alcohol or substance abuse
9. Currently pregnant
10. Use of any other investigational drug product within 30 days prior to treatment visit

Primary outcomes:
measure: Successful administration and acceptability of self-injection of sumatriptan under the skin using an investigational auto-injector will be assessed by use of patient-completed scales and a short questionnaire.
Secondary outcomes:
measure: • Comparison of pain scores pre-dose and 2 hours post-dose. • Preference of investigational auto-injector experience compared to subject's previous self-administration of sumatriptan.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: Stamford
country: United States
facility: New England Center for Headache
state: Connecticut
city: Chicago
country: United States
facility: Diamond Head Clinic
state: Illinois
city: Ann Arbor
country: United States
facility: Michigan Head Pain & Neurological Institute
state: Michigan
city: Springfield
country: United States
facility: Clinvest
state: Missouri
city: Pittsburgh
country: United States
facility: University of Pittsburgh Headache Center
state: Pennsylvania
city: Memphis
country: United States
facility: Wesley Headache Clinic
state: Tennessee
city: Dallas
country: United States
facility: Anodyne Headache and Pain Care
state: Texas
city: Houston
country: United States
facility: Houston Headache Clinic
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, LTD
state: Texas
Study officials:
References:
citation: Landy SH, Tepper SJ, Wein T, Schweizer E, Ramos E. An open-label trial of a sumatriptan auto-injector for migraine in patients currently treated with subcutaneous sumatriptan. Headache. 2013 Jan;53(1):118-125. doi: 10.1111/j.1526-4610.2012.02295.x. Epub 2012 Nov 13.