MigraineNCT01880671
Evaluation of a New Treatment for Migraine Attacks
A study testing Inactive Migraine Medical Device and Migraine Medical Device 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 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?
- Inactive Migraine Medical Device and Migraine Medical Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- May 2013to Mar 2014
- 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 disease
- Vascular damage on neck vessels
- Disease other than migraine of the CSN
- 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
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 post treatment.
- Conditions
- Migraine
- Being tested
- Inactive Migraine Medical Device, Migraine Medical Device
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactive Migraine Medical DeviceDevice
Migraine Medical DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Migraine Medical Device | Experimental | Not described Receives: Device: Migraine Medical Device |
| Inactive Migraine Medical Device | Placebo comparator | Not described Receives: Device: Inactive Migraine Medical Device |
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)
Measured: Estimated 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan-Erik Juto, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880671
- Sponsor's protocol ID
- Migraine2013/657-32
- Status last verified
- Mar 2014
- First submitted
- 17 Jun 2013
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Juto JE, Hallin RG. Kinetic oscillation stimulation as treatment of acute migraine: a randomized, controlled pilot study. Headache. 2015 Jan;55(1):117-27. doi: 10.1111/head.12485. Epub 2014 Dec 29.
PubMed 25546476
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Undersökning av ny Behandlingsmetod Vid migränanfall
- ClinicalTrials.gov ID
- NCT01880671
- Acronym / sponsor ID
- Migraine2013/657-32
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- First posted
- 19 Jun 2013 (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 post treatment.
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: Migraine Medical Device |
| Inactive Migraine Medical Device | Placebo comparator | Device: Inactive Migraine Medical Device |
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 disease
- Vascular damage on neck vessels
- Disease other than migraine of the CSN
- 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 |
|---|---|---|
| Inactive Migraine Medical Device | Device | Inactive Migraine Medical Device |
| Migraine Medical Device | Device | Migraine Medical Device |
Primary outcome
Change from baseline in pain intensity according to VAS-scales (0-10)
Time frame: Estimated 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
- Derived from this study: PubMed 25546476Juto JE, Hallin RG. Kinetic oscillation stimulation as treatment of acute migraine: a randomized, controlled pilot study. Headache. 2015 Jan;55(1):117-27. doi: 10.1111/head.12485. Epub 2014 Dec 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inactive Migraine Medical Device and Migraine Medical Device 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: finished, as of the sponsor's last update on 1 Apr 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Estimated 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01880671, which also lists 1 linked publication.
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 1 Apr 2014.