Evaluation of a New Treatment for Migraine Attacks

Migraine Clinical Trial

Official title:

Undersökning av ny Behandlingsmetod Vid migränanfall

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880671
• Other study ID #: Migraine2013/657-32
• Status: Completed
• Phase: N/A
• First received: June 17, 2013
• Last updated: March 31, 2014
• Start date: May 2013

Study information

• Verified date: March 2014
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine

Intervention

Device:
• Inactive Migraine Medical Device

• Migraine Medical Device

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital, Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain intensity according to VAS-scales (0-10)		Estimated 30 minutes	No