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出境医 / 临床实验 / Study on Indomethacin-responsive Headaches

Study on Indomethacin-responsive Headaches

Study Description
Brief Summary:
Description of modalities concerning the patient care of headaches sensible to indometacine.

Condition or disease Intervention/treatment
Headache, Migraine Drug: Indometacin

Detailed Description:
Description of clinical profile, treatment of crisis and background treatment
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non Interventional Study on Indomethacin-responsive Headaches
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Description of headaches sensible to indometacine [ Time Frame: 24 monthes ]
    Description of the clinical cases with headaches sensible to indometacine according to the type of headaches.


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 27, 2019
First Posted Date May 30, 2019
Last Update Posted Date May 30, 2019
Estimated Study Start Date June 1, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2019)
Description of headaches sensible to indometacine [ Time Frame: 24 monthes ]
Description of the clinical cases with headaches sensible to indometacine according to the type of headaches.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study on Indomethacin-responsive Headaches
Official Title Non Interventional Study on Indomethacin-responsive Headaches
Brief Summary Description of modalities concerning the patient care of headaches sensible to indometacine.
Detailed Description Description of clinical profile, treatment of crisis and background treatment
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient sufffuring from headaches or migraine and who is receiving Indometacine
Condition Headache, Migraine
Intervention Drug: Indometacin
patient who are taken indomatacin for headaches and migraine
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 27, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2021
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patient with a diagnosis of migraine with or without aura, or trigemino-autosomic headaches or other primary headaches
  • patient who are taking indometacine
  • patient with written consent form

Exclusion Criteria:

  • patient under 18 years
  • pregnant woman or breastfeeding patient
  • patient who refuses to participate
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03967483
Other Study ID Numbers 2019-A00406-51
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Anne Ducros, French Society for the Study of Migraine Headache
Study Sponsor Anne Ducros
Collaborators Not Provided
Investigators Not Provided
PRS Account French Society for the Study of Migraine Headache
Verification Date May 2019