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

Migraine Clinical Trial

Official title:

Undersökning av ny Behandlingsmetod Vid migränanfall (Evaluation of a New Treatment for Migraine Attacks)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01488110
• Other study ID #: Migraine2011/1609-31/2
• 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
• 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

• Migraine
• Migraine Disorders

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