| Condition or disease | Intervention/treatment |
|---|---|
| Headache, Migraine | Drug: Indometacin |
| 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 |
| 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 |
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.
|
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| 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 |
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| 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
|
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| 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. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
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:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| 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 |
|
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| 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 | ||||