- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03967483
Study on Indomethacin-responsive Headaches
May 27, 2019 updated by: Anne Ducros
Non Interventional Study on Indomethacin-responsive Headaches
Description of modalities concerning the patient care of headaches sensible to indometacine.
Study Overview
Detailed Description
Description of clinical profile, treatment of crisis and background treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anne DONNET
- Phone Number: 0491384340
- Email: Anne.DONNET@ap-hm.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 98 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient sufffuring from headaches or migraine and who is receiving Indometacine
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 monthes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2019
Primary Completion (Anticipated)
June 1, 2020
Study Completion (Anticipated)
June 1, 2021
Study Registration Dates
First Submitted
May 27, 2019
First Submitted That Met QC Criteria
May 27, 2019
First Posted (Actual)
May 30, 2019
Study Record Updates
Last Update Posted (Actual)
May 30, 2019
Last Update Submitted That Met QC Criteria
May 27, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Headache
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Reproductive Control Agents
- Gout Suppressants
- Tocolytic Agents
- Indomethacin
Other Study ID Numbers
- 2019-A00406-51
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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