Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Evaluation of a New Treatment for Migraine Attacks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01880671
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):
Jan-Erik Juto, Karolinska University Hospital

Tracking Information
First Submitted Date  ICMJE June 17, 2013
First Posted Date  ICMJE June 19, 2013
Last Update Posted Date April 1, 2014
Study Start Date  ICMJE May 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
Change from baseline in pain intensity according to VAS-scales (0-10) [ Time Frame: Estimated 30 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01880671 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a New Treatment for Migraine Attacks
Official Title  ICMJE Undersökning av ny Behandlingsmetod Vid migränanfall
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Device: Inactive Migraine Medical Device
  • Device: Migraine Medical Device
Study Arms  ICMJE
  • Experimental: Migraine Medical Device
    Intervention: Device: Migraine Medical Device
  • Placebo Comparator: Inactive Migraine Medical Device
    Intervention: Device: Inactive Migraine Medical Device
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2014)
36
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2013)
40
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01880671
Other Study ID Numbers  ICMJE Migraine2013/657-32
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jan-Erik Juto, Karolinska University Hospital
Study Sponsor  ICMJE Karolinska University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Karolinska University Hospital
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP