Study Stopped
Too slow recruitment rate. The study has been terminated and will be re-started with an improved and more suitable study design.
Investigation of Efficacy and Outcome of a New Medical Device for Treatment of Migraine
Undersökning av ny Behandlingsmetod Vid migränanfall (Evaluation of a New Treatment for Migraine Attacks)
1 other identifier
interventional
40
1 country
1
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 two months post treatment. Another purpose is to investigate if and how this treatment affects manifestations of the autonomic nervous system activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2011
CompletedFirst Posted
Study publicly available on registry
December 8, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedJune 18, 2013
June 1, 2013
December 2, 2011
June 17, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
RR (Heart rate)-interval
Estimation 40 minutes
Change from baseline in sympathetic nervous system activity
Estimation 40 minutes
Blood pressure
Estimation 40 minutes
Change from baseline in attack frequency based on completed patient diaries
3 to 4 months
Change from baseline in attack intensity based on completed patient diaries
3 to 4 months
- +2 more secondary outcomes
Study Arms (2)
Migraine medical device
EXPERIMENTALTreatment with an active nasal probe
Inactive migraine medical device
PLACEBO COMPARATORTreatment with an inactive nasal probe.
Interventions
30 minutes treatment with an active nasal probe.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska University Hospital, Huddinge
Stockholm, 14186, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juto
Karolinska University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct professor
Study Record Dates
First Submitted
December 2, 2011
First Posted
December 8, 2011
Study Start
January 1, 2012
Last Updated
June 18, 2013
Record last verified: 2013-06