Investigation of Efficacy and Outcome of a New Medical Device for Treatment of Migraine

NCT ID: NCT01488110

Last Updated: 2013-06-18

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

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

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 two months post treatment. Another purpose is to investigate if and how this treatment affects manifestations of the autonomic nervous system activity.

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

Treatment with an active nasal probe

Group Type EXPERIMENTAL

In-house prototype invented by Jan-Erik Juto

Intervention Type DEVICE

30 minutes treatment with an active nasal probe.

Inactive migraine medical device

Treatment with an inactive nasal probe.

Group Type PLACEBO_COMPARATOR

In-house prototype invented by Jan-Erik Juto

Intervention Type DEVICE

30 minutes treatment with an inactive nasal probe.

Interventions

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In-house prototype invented by Jan-Erik Juto

30 minutes treatment with an active nasal probe.

Intervention Type DEVICE

In-house prototype invented by Jan-Erik Juto

30 minutes treatment with an inactive nasal probe.

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 diseases
* Vascular damages on neck vessels
* Diseases other than migraine of the CNS
* 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

Adjunct professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juto

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Karolinska University Hospital, Huddinge

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Migraine2011/1609-31/2

Identifier Type: -

Identifier Source: org_study_id

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