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Evaluation of a New Treatment for Migraine Attacks

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Inactive Migraine Medical Device
Migraine Medical Device
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska University Hospital, Huddinge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Migraine Medical Device

Inactive Migraine Medical Device

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 17, 2013
Last Updated
March 31, 2014
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01880671
Brief Title
Evaluation of a New Treatment for Migraine Attacks
Official Title
Undersökning av ny Behandlingsmetod Vid migränanfall
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Migraine Medical Device
Arm Type
Experimental
Arm Title
Inactive Migraine Medical Device
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Inactive Migraine Medical Device
Intervention Type
Device
Intervention Name(s)
Migraine Medical Device
Primary Outcome Measure Information:
Title
Change from baseline in pain intensity according to VAS-scales (0-10)
Time Frame
Estimated 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Karolinska University Hospital, Huddinge
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25546476
Citation
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.
Results Reference
derived

Learn more about this trial

Evaluation of a New Treatment for Migraine Attacks

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