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Evaluation of a New Treatment for Migraine Attacks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01880671
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : April 1, 2014
Information provided by (Responsible Party):
Jan-Erik Juto, 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.

Condition or disease Intervention/treatment Phase
Migraine Device: Inactive Migraine Medical Device Device: Migraine Medical Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Undersökning av ny Behandlingsmetod Vid migränanfall
Study Start Date : May 2013
Actual Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Migraine Medical Device Device: Migraine Medical Device
Placebo Comparator: Inactive Migraine Medical Device Device: Inactive Migraine Medical Device

Primary Outcome Measures :
  1. Change from baseline in pain intensity according to VAS-scales (0-10) [ Time Frame: Estimated 30 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01880671

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Karolinska University Hospital, Huddinge
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jan-Erik Juto, Affiliated professor, Karolinska University Hospital Identifier: NCT01880671     History of Changes
Other Study ID Numbers: Migraine2013/657-32
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases