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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01488110
Other study ID # Migraine2011/1609-31/2
Secondary ID
Status Terminated
Phase N/A
First received December 2, 2011
Last updated June 17, 2013
Start date January 2012

Study information

Verified date June 2013
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 two months post treatment. Another purpose is to investigate if and how this treatment affects manifestations of the autonomic nervous system activity.


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date
Est. primary completion date
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 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
In-house prototype invented by Jan-Erik Juto
30 minutes treatment with an active nasal probe.
In-house prototype invented by Jan-Erik Juto
30 minutes treatment with an inactive nasal probe.

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) Documentation of pain intensity prior to treatment initiation (baseline value), every 5 minutes during treatment and post treatment. Estimation 40 minutes No
Secondary RR (Heart rate)-interval ECG will be obtained during treatment Estimation 40 minutes Yes
Secondary Change from baseline in sympathetic nervous system activity Plethysmographic measurements will be obtained during treatment (finger clamp on finger). Estimation 40 minutes No
Secondary Blood pressure Will be obtained prior to treatment initiation and post treatment Estimation 40 minutes No
Secondary Change from baseline in attack frequency based on completed patient diaries 3 to 4 months No
Secondary Change from baseline in attack intensity based on completed patient diaries 3 to 4 months No
Secondary Change from baseline in attack duration based on completed patient diaries 3 to 4 months No
Secondary Change from baseline in medicine consumption based on completed patient diaries 3 to 4 months No
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