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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
History of Changes

November 18, 2009
November 28, 2011
November 2009
April 2010   (final data collection date for primary outcome measure)
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)
Patient Perception of Migraine Questionnaire Revised (PPMQ-R) [ Time Frame: After 4 migraines or 60 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01016834 on ClinicalTrials.gov Archive Site
  • 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.
  • Treatment preference [ Time Frame: After 4 migraines or 60 days ] [ Designated as safety issue: No ]
  • Treatment confidence [ Time Frame: After 4 migraines or 60 days ] [ Designated as safety issue: No ]
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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Migraine
  • 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)
Interventions:
  • Device: Sumavel DosePro
  • Drug: Sumatriptan

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01016834
ZX001-0901
No
Zogenix, Inc.
Zogenix, Inc.
Synteract, Inc.
Study Chair: Roger K Cady, MD Clinvest/A Division of Banyan Group Inc
Zogenix, Inc.
November 2011

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