Evaluation of a New Treatment for Migraine Attacks

Karolinska University Hospital36 enrolled

Overview

The purpose of this study is to evaluate the efficacy of a novel therapy for treatment of migraine, pain reduction and relief of associated symptoms during ongoing migraine attacks, and presence of a preventive effect post treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Migraine

Interventions

Inactive Migraine Medical DeviceDEVICE

Migraine Medical DeviceDEVICE

Eligibility

Sex: ALLMin age: 20 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female or male subjects, in otherwise good health, 20 to 55 years of age * Subjects who meet the ICHD-2 (2nd Edition of The International Headache Classification) criteria for migraine headache * Subjects with a minimum of 1 migraine attack per month * Attack duration of 4 to 72 hours * Normal attack intensity of at least 4 on a 0-10 VAS-scale Exclusion Criteria: * Completed heart surgery * Cardiovascular disease * Vascular damage on neck vessels * Disease other than migraine of the CSN * Severe disease of vital body organs * Severe psychiatric disorders * More than 6 migraine attacks per month

Locations (1)

Karolinska University Hospital, Huddinge

Stockholm, Sweden

Outcomes

Primary Outcomes

Change from baseline in pain intensity according to VAS-scales (0-10)

Time frame: Estimated 30 minutes

Data from ClinicalTrials.gov

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