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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016834
• Other study ID #: ZX001-0901
• Status: Completed
• Phase: Phase 4
• First received: November 18, 2009
• Last updated: November 28, 2011
• Start date: November 2009
• Est. completion date: April 2010

Study information

• Verified date: November 2011
• Source: Zogenix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Michigan Head, Pain, & Neurological Institute	Ann Arbor	Michigan
United States	Comprehensive Neurosciences Inc	Atlanta	Georgia
United States	University of Alabama Hospital, Dept. of Neurology	Birmingham	Alabama
United States	Alpine Clinical Research	Boulder	Colorado
United States	Diamond Headache Clinic	Chicago	Illinois
United States	Neurological Medicine	Clarksville	Tennessee
United States	Cleveland Clinic: Neurological Center for Pain	Cleveland	Ohio
United States	Neurology Specialists of Decatur	Decatur	Georgia
United States	Regional Clinical Research Inc	Endwell	New York
United States	Headache Wellness Center	Greensboro	North Carolina
United States	Nashville Neuroscience Group	Nashville	Tennessee
United States	C. Phillip O'Carroll, MD, Inc	Newport Beach	California
United States	Meridian Clinical Research	Omaha	Nebraska
United States	University Clinical Research Inc.	Pembroke Pines	Florida
United States	Jefferson Headache Center	Philadelphia	Pennsylvania
United States	Arizona Research Center	Phoenix	Arizona
United States	Mercy Health Research	Saint Louis	Missouri
United States	California Medical Clinic for Headache	Santa Monica	California
United States	Swedish Pain and Headache Center	Seattle	Washington
United States	Clinvest/A Division of Banyan Group, Inc	Springfield	Missouri
United States	Comprehensive Neuroscience Inc	St Petersburg	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Zogenix, Inc.	Synteract, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Satisfaction	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)	After 4 migraines or 60 days	No
Secondary	Treatment Preference	Number of subjects preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).	After 4 migraines or 60 days	No
Secondary	Treatment Confidence	Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.	After 4 migraines or 60 days	No