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

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Pfizer

Status and phase

Completed
Phase 3

Conditions

Migraine

Treatments

Drug: "Investigational"Auto-injector (sumatriptan succinate)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00510419
K644-07-3001

Details and patient eligibility

About

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.

Full description

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]

Enrollment

73 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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