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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01016834
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : December 29, 2011
Last Update Posted : December 29, 2011
Synteract, Inc.
Information provided by (Responsible Party):
Zogenix, Inc.

November 18, 2009
November 20, 2009
November 28, 2011
December 29, 2011
December 29, 2011
November 2009
April 2010   (Final data collection date for primary outcome measure)
Overall Satisfaction [ Time Frame: After 4 migraines or 60 days ]
Change from baseline in overall subject satisfaction with migraine treatments. Patient Perception of Migraine Questionnaire-Revised, question 3c "Overall satisfaction" was the measure. Baseline measured subjects satisfaction with past migraine treatments. End of study measured subject's satisfaction with migraine treatment by Sumavel DosePro. PPMQ-R scale (1-7 scale; 1=very satisfied)is transformed to a 0-100 scale (100=very satisfied)
Patient Perception of Migraine Questionnaire Revised (PPMQ-R) [ Time Frame: After 4 migraines or 60 days ]
Complete list of historical versions of study NCT01016834 on Archive Site
  • Treatment Preference [ Time Frame: After 4 migraines or 60 days ]
    Number of subjects preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).
  • Treatment Confidence [ Time Frame: After 4 migraines or 60 days ]
    Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.
  • Treatment Preference [ Time Frame: After 4 migraines or 60 days ]
  • Treatment Confidence [ Time Frame: After 4 migraines or 60 days ]
Not Provided
Not Provided
Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine
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
The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.
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.
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Device: Sumavel DosePro
    Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration
  • Drug: Sumatriptan
    subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period
    Other Name: Sumavel DosePro (Sumatriptan injection)
Sumavel(R) DosePro(R)
Single arm study (Sumavel DosePro)
  • Device: Sumavel DosePro
  • Drug: Sumatriptan

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Zogenix, Inc.
Zogenix, Inc.
Synteract, Inc.
Study Chair: Roger K Cady, MD Clinvest
Zogenix, Inc.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP