MigraineNCT01488110
Investigation of Efficacy and Outcome of a New Medical Device for Treatment of Migraine
A study testing In-house prototype invented by Jan-Erik Juto in people with Migraine, run by Karolinska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Migraine
- What is being tested?
- In-house prototype invented by Jan-Erik Juto
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2012to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Undersökning av ny Behandlingsmetod Vid migränanfall (Evaluation of a New Treatment for Migraine Attacks)
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.
- Conditions
- Migraine
- Being tested
- In-house prototype invented by Jan-Erik Juto
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-house prototype invented by Jan-Erik JutoDevice
30 minutes treatment with an active nasal probe.
In-house prototype invented by Jan-Erik JutoDevice
30 minutes treatment with an inactive nasal probe.
| Study group | Role | What they receive |
|---|---|---|
| Migraine medical device | Experimental | Treatment with an active nasal probe Receives: Device: In-house prototype invented by Jan-Erik Juto |
| Inactive migraine medical device | Placebo comparator | Treatment with an inactive nasal probe. Receives: Device: In-house prototype invented by Jan-Erik Juto |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Estimation 40 minutes
Secondary outcomes (7)
RR (Heart rate)-interval
ECG will be obtained during treatment
Measured: Estimation 40 minutes
Change from baseline in sympathetic nervous system activity
Plethysmographic measurements will be obtained during treatment (finger clamp on finger).
Measured: Estimation 40 minutes
Blood pressure
Will be obtained prior to treatment initiation and post treatment
Measured: Estimation 40 minutes
Change from baseline in attack frequency based on completed patient diaries
Measured: 3 to 4 months
Change from baseline in attack intensity based on completed patient diaries
Measured: 3 to 4 months
Change from baseline in attack duration based on completed patient diaries
Measured: 3 to 4 months
Change from baseline in medicine consumption based on completed patient diaries
Measured: 3 to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startJan 2012
Why it stopped: Too slow recruitment rate. The study has been terminated and will be re-started with an improved and more suitable study design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan-Erik Juto, Karolinska University Hospital
- Investigators
- Juto, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488110
- Sponsor's protocol ID
- Migraine2011/1609-31/2
- Status last verified
- Jun 2013
- First submitted
- 2 Dec 2011
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Undersökning av ny Behandlingsmetod Vid migränanfall (Evaluation of a New Treatment for Migraine Attacks)
- ClinicalTrials.gov ID
- NCT01488110
- Acronym / sponsor ID
- Migraine2011/1609-31/2
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too slow recruitment rate. The study has been terminated and will be re-started with an improved and more suitable study design.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraine medical device | Experimental | Device: In-house prototype invented by Jan-Erik JutoTreatment with an active nasal probe |
| Inactive migraine medical device | Placebo comparator | Device: In-house prototype invented by Jan-Erik JutoTreatment with an inactive nasal probe. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Completed heart surgery
- Cardiovascular diseases
- Vascular damages on neck vessels
- Diseases other than migraine of the CNS
- Severe disease of vital body organs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-house prototype invented by Jan-Erik Juto30 minutes treatment with an active nasal probe. | Device | Migraine medical device |
| In-house prototype invented by Jan-Erik Juto30 minutes treatment with an inactive nasal probe. | Device | Inactive migraine medical device |
Primary outcome
Change from baseline in pain intensity according to VAS-scales (0-10)
Time frame: Estimation 40 minutes
Documentation of pain intensity prior to treatment initiation (baseline value), every 5 minutes during treatment and post treatment.
7 secondary outcomes
RR (Heart rate)-interval
Time frame: Estimation 40 minutes
Change from baseline in sympathetic nervous system activity
Time frame: Estimation 40 minutes
Blood pressure
Time frame: Estimation 40 minutes
Change from baseline in attack frequency based on completed patient diaries
Time frame: 3 to 4 months
Change from baseline in attack intensity based on completed patient diaries
Time frame: 3 to 4 months
Change from baseline in attack duration based on completed patient diaries
Time frame: 3 to 4 months
Change from baseline in medicine consumption based on completed patient diaries
Time frame: 3 to 4 months
Results and safety
The study was stopped early (reason given: Too slow recruitment rate. The study has been terminated and will be re-started with an improved and more suitable study design.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juto principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-house prototype invented by Jan-Erik Juto in people with Migraine, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Too slow recruitment rate. The study has been terminated and will be re-started with an improved and more suitable study design.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain intensity according to VAS-scales (0-10) (time frame: Estimation 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013.