NCT01880671

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

April 1, 2014

Status Verified

March 1, 2014

Enrollment Period

10 months

First QC Date

June 17, 2013

Last Update Submit

March 31, 2014

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in pain intensity according to VAS-scales (0-10)

    Estimated 30 minutes

Study Arms (2)

Migraine Medical Device

EXPERIMENTAL
Device: Migraine Medical Device

Inactive Migraine Medical Device

PLACEBO COMPARATOR
Device: Inactive Migraine Medical Device

Interventions

Inactive Migraine Medical DeviceDEVICE
Inactive Migraine Medical Device
Migraine Medical DeviceDEVICE
Migraine Medical Device

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital, Huddinge

Stockholm, 14186, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 25546476DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

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
Affiliated professor

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 19, 2013

Study Start

May 1, 2013

Primary Completion

March 1, 2014

Last Updated

April 1, 2014

Record last verified: 2014-03

Locations

SE(1)