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Completed

NCT Number: NCT01016834

Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine

The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.

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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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama Hospital, Dept. of Neurology, Birmingham, Alabama, United States

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About this study

Single arm, open-label, multicenter study to evaluate the treatment satisfaction, treatment confidence, and subject preference for Sumavel DosePro in adult subjects diagnosed with migraines and currently treated with triptans. Subjects will treat up to 4 migraines over a 60 day period and complete migraine diaries and questionnaires.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • History of 2 to 6 migraine headaches per month
  • Migraines should have been present for at least 1 year with age at onset of migraine less than 50 years
  • History of 24 hours of freedom between migraine attacks
  • Current users of triptan medications
  • Able to distinguish interval or other non-migrainous headaches from typical migraine
  • General good health

Exclusion criteria

  • History or symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes
  • Significant underlying cardiovascular diseases including uncontrolled hypertension
  • Hemiplegic or basilar migraine
  • History or diagnosis of severe hepatic or renal impairment
  • History of epilepsy or seizure or other serious neurologic condition
  • History of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs including sulphonamides
  • History of scleroderma (systemic sclerosis)
  • Pregnant or breastfeeding
  • Use of contraindicated prescription medications, monoamine oxidase inhibitors (MAO-A), selective serotonin reuptake inhibitors, or lithium agents

Treatment and study plan

Sumavel DosePro

Device

Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration

Sumatriptan

Drug

subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period

Other names: Sumavel DosePro (Sumatriptan injection)

Primary outcomes

  1. Overall Treatment Satisfaction at the End of the Treatment

    Time frame: At the end of the treatment (after 4 migraines or 60 days, whichever came first)

    Overall participant satisfaction with migraine treatment Sumavel DosePro was measured using the Patient Perception of Migraine Questionnaire-Revised (PPMQ-R), question 3c "Overall satisfaction". The PPMQ-R scores (scale ranges from 1-7 with 1=very satisfied) were transformed to a 0-100 scale with higher scores indicating a higher level of treatment satisfaction (100=very satisfied).

Secondary outcomes

  1. Treatment Preference

    Time frame: After 4 migraines or 60 days whichever came first

    Number of participants preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).

  2. Treatment Confidence

    Time frame: After 4 migraines or 60 days whichever came first

    Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.

Sponsors and collaborators

Lead sponsor

Zogenix, Inc.

Industry

Collaborators

  • Synteract, Inc.

Registry information

Official study title

A Multicenter, Open-label Evaluation of Treatment Satisfaction, Tolerability, Safety and Preference for Sumavel DosePro for Treatment of Migraine in Subjects Currently Treated With Triptans

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 20, 2009
Registry last updated
Jun 8, 2026

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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