Evaluation of a New Treatment for Migraine Attacks

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Device: Migraine Medical Device; Device: Inactive Migraine Medical Device

• Registration Number: NCT01880671
• Lead Sponsor: Karolinska University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-19
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Last Update Submitted: 2014-03-31
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Migraine Medical Device	Migraine Medical Device	-
Inactive Migraine Medical Device	Inactive Migraine Medical Device	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in pain intensity according to VAS-scales (0-10)	Estimated 30 minutes

Trial Locations

Locations (1)

Karolinska University Hospital, Huddinge; 🇸🇪 Stockholm, Sweden