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Investigation of Efficacy and Outcome of a New Medical Device for Treatment of Migraine

This study has been terminated.
(Too slow recruitment rate. The study has been terminated and will be re-started with an improved and more suitable study design.)
Sponsor:
Information provided by (Responsible Party):
Jan-Erik Juto, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01488110
First received: December 2, 2011
Last updated: June 17, 2013
Last verified: June 2013

December 2, 2011
June 17, 2013
January 2012
Not Provided
Change from baseline in pain intensity according to VAS-scales (0-10) [ Time Frame: Estimation 40 minutes ] [ Designated as safety issue: No ]
Documentation of pain intensity prior to treatment initiation (baseline value), every 5 minutes during treatment and post treatment.
Same as current
Complete list of historical versions of study NCT01488110 on ClinicalTrials.gov Archive Site
  • RR (Heart rate)-interval [ Time Frame: Estimation 40 minutes ] [ Designated as safety issue: Yes ]
    ECG will be obtained during treatment
  • Change from baseline in sympathetic nervous system activity [ Time Frame: Estimation 40 minutes ] [ Designated as safety issue: No ]
    Plethysmographic measurements will be obtained during treatment (finger clamp on finger).
  • Blood pressure [ Time Frame: Estimation 40 minutes ] [ Designated as safety issue: No ]
    Will be obtained prior to treatment initiation and post treatment
  • Change from baseline in attack frequency based on completed patient diaries [ Time Frame: 3 to 4 months ] [ Designated as safety issue: No ]
  • Change from baseline in attack intensity based on completed patient diaries [ Time Frame: 3 to 4 months ] [ Designated as safety issue: No ]
  • Change from baseline in attack duration based on completed patient diaries [ Time Frame: 3 to 4 months ] [ Designated as safety issue: No ]
  • Change from baseline in medicine consumption based on completed patient diaries [ Time Frame: 3 to 4 months ] [ Designated as safety issue: No ]
  • RR (Heart rate)-interval [ Time Frame: Estimation 40 minutes ] [ Designated as safety issue: Yes ]
    ECG will be obtained during treatment
  • Plethysmography [ Time Frame: Estimation 40 minutes ] [ Designated as safety issue: Yes ]
    Will be obtained during treatment
  • Blood pressure [ Time Frame: Estimation 40 minutes ] [ Designated as safety issue: Yes ]
    Will be obtained prior to treatment initiation and post treatment
  • Change from baseline in attack frequency based on completed patient diaries [ Time Frame: 3 to 4 months ] [ Designated as safety issue: No ]
  • Change from baseline in attack intensity based on completed patient diaries [ Time Frame: 3 to 4 months ] [ Designated as safety issue: No ]
  • Change from baseline in attack duration based on completed patient diaries [ Time Frame: 3 to 4 months ] [ Designated as safety issue: No ]
  • Change from baseline in medicine consumption based on completed patient diaries [ Time Frame: 3 to 4 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Investigation of Efficacy and Outcome of a New Medical Device for Treatment of Migraine
Undersökning av ny Behandlingsmetod Vid migränanfall (Evaluation of a New Treatment for Migraine Attacks)

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 two months post treatment. Another purpose is to investigate if and how this treatment affects manifestations of the autonomic nervous system activity.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Migraine
  • Device: In-house prototype invented by Jan-Erik Juto
    30 minutes treatment with an active nasal probe.
  • Device: In-house prototype invented by Jan-Erik Juto
    30 minutes treatment with an inactive nasal probe.
  • Experimental: Migraine medical device
    Treatment with an active nasal probe
    Intervention: Device: In-house prototype invented by Jan-Erik Juto
  • Placebo Comparator: Inactive migraine medical device
    Treatment with an inactive nasal probe.
    Intervention: Device: In-house prototype invented by Jan-Erik Juto
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
Not Provided
Not Provided

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 diseases
  • Vascular damages on neck vessels
  • Diseases other than migraine of the CNS
  • Severe disease of vital body organs
  • Severe psychiatric disorders
  • More than 6 migraine attacks per month
Both
20 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01488110
Migraine2011/1609-31/2
No
Jan-Erik Juto, Karolinska University Hospital
Karolinska University Hospital
Not Provided
Principal Investigator: Juto Karolinska University Hospital
Karolinska University Hospital
June 2013

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