A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack

A Phase 3 Open-Label Study to Assess Subcutaneous Self-Injection With Sumatriptan Succinate Using an Auto-injector During a Single Migraine Attack

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00510419

Enrollment

Registered

2007-08-02

Start date

2007-07-31

Completion date

2007-12-31

Last updated

2012-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Migraine

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 \[Visit 3 / Telephone follow-up 7-10 days after study drug administration\]

Interventions

DRUGInvestigationalAuto-injector (sumatriptan succinate)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
• 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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026