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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.

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

Condition or disease Intervention/treatment Phase
Migraine Device: Sumavel DosePro Drug: Sumatriptan Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Sumavel(R) DosePro(R)
Single arm study (Sumavel DosePro)
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)

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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).

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01016834

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Sponsors and Collaborators
Zogenix, Inc.
Synteract, Inc.
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Study Chair: Roger K Cady, MD Clinvest

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Zogenix, Inc. Identifier: NCT01016834     History of Changes
Other Study ID Numbers: ZX001-0901
First Posted: November 20, 2009    Key Record Dates
Results First Posted: December 29, 2011
Last Update Posted: December 29, 2011
Last Verified: November 2011

Keywords provided by Zogenix, Inc.:
treatment satisfaction

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs