Headache, MigraineNCT03967483
Study on Indomethacin-responsive Headaches
An observational study of Headache, Migraine, run by Anne Ducros.
Trial summary
Description of modalities concerning the patient care of headaches sensible to indometacine. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- Indometacin
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient sufffuring from headaches or migraine and who is receiving Indometacine
Who may be able to join
- 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
Who cannot join
- patient under 18 years
- pregnant woman or breastfeeding patient
- patient who refuses to participate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Non Interventional Study on Indomethacin-responsive Headaches
Description of modalities concerning the patient care of headaches sensible to indometacine.
Read the detailed description
Description of clinical profile, treatment of crisis and background treatment
- Conditions
- Headache, Migraine
- Being tested
- Indometacin
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndometacinDrug
patient who are taken indomatacin for headaches and migraine
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of headaches sensible to indometacine
Description of the clinical cases with headaches sensible to indometacine according to the type of headaches.
Measured: 24 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anne Ducros
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anne Ducros, French Society for the Study of Migraine Headache
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967483
- Sponsor's protocol ID
- 2019-A00406-51
- Status last verified
- May 2019
- First submitted
- 27 May 2019
- Last updated
- 30 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Interventional Study on Indomethacin-responsive Headaches
- ClinicalTrials.gov ID
- NCT03967483
- Acronym / sponsor ID
- 2019-A00406-51
- Conditions
- Headache, Migraine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anne DucrosUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient sufffuring from headaches or migraine and who is receiving Indometacine
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- patient under 18 years
- pregnant woman or breastfeeding patient
- patient who refuses to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indometacinpatient who are taken indomatacin for headaches and migraine | Drug | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
Related trials for Headache, Migraine
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
Migraine
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
Migraine
RecruitingPhase 3
A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
Acute Migraine
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
Migraine
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, Migraine, run by Anne Ducros.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne DONNET (0491384340, Anne.DONNET@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of headaches sensible to indometacine (time frame: 24 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.