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Completed

NCT Number: NCT00510419

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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

San Francisco Clinical Research Center, San Francisco, California, United States

Loading trial locations.

About this study

Investigational Plan:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Seizure disorders
  • Coronary artery disease (CAD)
  • Cardiac dysrhythmia or pacemaker
  • High blood pressure
  • Liver disease
  • Kidney disease
  • Autoimmune disease
  • History of alcohol or substance abuse
  • Currently pregnant
  • Use of any other investigational drug product within 30 days prior to treatment visit

Treatment and study plan

"Investigational"Auto-injector (sumatriptan succinate)

Drug

Primary outcomes

  1. 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

  1. • 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 2, 2007
Registry last updated
Jun 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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