Evaluation of a New Treatment for Migraine Attacks | NCT01880671

Studies
Evaluation of a New Treatment for Migraine Attacks

NCT01880671

Sponsor

Karolinska University Hospital

Status

Completed

Last Update Posted

Apr 1, 2014Estimated

Enrollment

36Actual

Phase

Not Applicable

Conditions

Migraine

Interventions

Inactive Migraine Medical Device
Migraine Medical Device

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Mar 2014Actual

Completion Date

Not provided

First Submitted Date

Jun 17, 2013

First Submission Date that Met QC Criteria

Jun 17, 2013

First Posted Date

Jun 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2014

Last Update Posted Date

Apr 1, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 post treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Migraine Medical Device	Experimental		Device: Migraine Medical Device
Inactive Migraine Medical Device	Placebo Comparator		Device: Inactive Migraine Medical Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inactive Migraine Medical Device	Device		Inactive Migraine Medical Device
Migraine Medical Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in pain intensity according to VAS-scales (0-10)		Estimated 30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital, Huddinge		Stockholm		14186	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25546476	Derived	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.

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases