Evaluation of a New Treatment for Migraine Attacks

NCT ID: NCT01880671

Last Updated: 2014-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Brief Summary

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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

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Migraine Medical Device

Group Type EXPERIMENTAL

Migraine Medical Device

Intervention Type DEVICE

Inactive Migraine Medical Device

Group Type PLACEBO_COMPARATOR

Inactive Migraine Medical Device

Intervention Type DEVICE

Interventions

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Inactive Migraine Medical Device

Intervention Type DEVICE

Migraine Medical Device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jan-Erik Juto

Affiliated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska University Hospital, Huddinge

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Juto JE, Hallin RG. Kinetic oscillation stimulation as treatment of acute migraine: a randomized, controlled pilot study. Headache. 2015 Jan;55(1):117-27. doi: 10.1111/head.12485. Epub 2014 Dec 29.

Reference Type DERIVED
PMID: 25546476 (View on PubMed)

Other Identifiers

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Migraine2013/657-32

Identifier Type: -

Identifier Source: org_study_id

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