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

This study has been completed.
Sponsor:
Collaborator:
Synteract, Inc.
Information provided by (Responsible Party):
Zogenix, Inc.
ClinicalTrials.gov Identifier:
NCT01016834
First received: November 18, 2009
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Migraine
Device: Sumavel DosePro
Drug: Sumatriptan
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Zogenix, Inc.:

Primary Outcome Measures:
  • Overall Satisfaction [ Time Frame: After 4 migraines or 60 days ] [ Designated as safety issue: No ]
    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:
  • Treatment Preference [ Time Frame: After 4 migraines or 60 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.


Enrollment: 246
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016834

  Show 21 Study Locations
Sponsors and Collaborators
Zogenix, Inc.
Synteract, Inc.
Investigators
Study Chair: Roger K Cady, MD Clinvest/A Division of Banyan Group Inc
  More Information

No publications provided by Zogenix, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT01016834     History of Changes
Other Study ID Numbers: ZX001-0901
Study First Received: November 18, 2009
Results First Received: November 28, 2011
Last Updated: November 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Zogenix, Inc.:
migraine
treatment satisfaction

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

ClinicalTrials.gov processed this record on September 18, 2014