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

Zogenix

Status and phase

Completed

Phase 4

Conditions

Migraine

Treatments

Drug: Sumatriptan

Device: Sumavel DosePro

Study type

Interventional

Funder types

Industry

Identifiers

NCT01016834

ZX001-0901

Details and patient eligibility

About

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

Full 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.

Enrollment

246 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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