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OpenTrials
Completed

NCT Number: NCT01880671

Evaluation of a New Treatment for Migraine Attacks

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital, Huddinge

Stockholm, 14186, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inactive Migraine Medical Device

Device

Migraine Medical Device

Device

Primary outcomes

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

    Time frame: Estimated 30 minutes

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

Undersökning av ny Behandlingsmetod Vid migränanfall

Important dates

Study start
2013
Primary completion
2014
First posted
Jun 19, 2013
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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