EpilepsyEPIRARENCT05126914
Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents
An observational study of Epilepsy and West Syndrome, run by Assistance Publique - Hôpitaux de Paris at 11 sites in France.
Trial summary
Rare epilepsies as a whole account for 20-30% of epilepsies, but knowledge about prognostic factors is currently limited. This means that it is difficult to provide adequate information to families at diagnosis and during follow-up. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Epilepsy, West Syndrome, Dravet Syndrome
- How many people
- 1,000 participants
- Where
- 11 sitesFrance
- Study dates
- 11 Dec 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: The population studied in this work will be a pediatric population: from birth to the end of adolescence. There is no limitation in the epileptic syndromes provided that it is a rare epilepsy according to the waxers with a prevalence of 1 in 2000. As mentioned here on several occasions, there is little data on it. efficacy of treatments and the outcome of rare epilepsies. A fairly wide opening on the syndromes to be included will make it possible to collect data without being limited to those which are the subject of the most frequent publications and therefore provide data not available to date.
Who may be able to join
- Diagnosis for rare epilepsy (based on ORPHA codes)
- holders of parental authority not opposed
- Be followed in one of the declared centers of the study
Who cannot join
- opposition from the holders of parental authority or the patient
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
CHU Angers
Angers, 49933
Patrick VAN BOGAERT, MD, 0033(0)241354445, patrick.vanbogaert@chu-angers.fr
- Recruiting
CHU de Bordeaux
Bordeaux, 33076
Frederic VILLEGA, MD, 0033(0)556795626, frederic.villega@chu-bordeaux.fr
- Recruiting
CHU de Brest - Hôpital de la Cavale Blanche
Brest, 29200
Jérémie LEFRANC, MD, 0033(0)298223346, jeremie.lefranc@chu-brest.fr
- Recruiting
CHRU Lille
Lille, 59000
Adeline TRAUFFLER, MD, 0033(0)320445962, adeline.trauffler@chru-lille.fr
- Recruiting
HFME - HospiceS Civils De Lyon
Lyon, 69000
Dorothée VILLE, MD, 0033(0)427855381, dorothee.ville@chu-lyon.fr
- Recruiting
Hôpital La Timone - APHM
Marseille, 13005
Mathieu MILH, Prof., 0033(0)491986807, Mathieu.MILH@ap-hm.fr
- Recruiting
Hôpital Necker - APHP
Paris, 75015
Rima Nabbout, prof., 0033(0)144494008, rima.nabbout@aphp.fr
- Recruiting
Hopital Robert Debré - Neurologie
Paris, 75019
Blandine DOZIERES, Dr, 0140033667 ext. +33, blandine.dozieres@aphp.fr
- Recruiting
CHU Strasbourg- Hôpital de Hautepierre
Strasbourg, 67098
Anne DE SAINT MARTIN, MD, 0033(0)388128328, anne.desaintmartin@chru-strasbourg.fr
- Recruiting
Hôpital Purpan - CHU de Toulouse
Toulouse, 31000
Marine HACHON LE CAMUS, MD, 033(0)534557423, hachonlecamus.c@chu-toulouse.fr
- Recruiting
CHU de Tours - hôpital Clocheville
Tours, 37044
Maximilien PERIVIEN, MD, 0033(0)247474757, m.perivier@chu-tours.fr
About this study
Rare epilepsies as a whole account for 20-30% of epilepsies, but knowledge about prognostic factors is currently limited. This means that it is difficult to provide adequate information to families at diagnosis and during follow-up. Prognostic factors are also important for management as they can have an impact on the patient's outcome (time to intervention, choice of one molecule over another, etc.). Finally, few treatments are currently available for these epilepsies. One of the limitations to the development of treatments is the lack of real life data as it is difficult to create reliable primary endpoints such as the rate of patients becoming seizure free naturally compared to a therapeutic intervention.
The aim of this real-life study is to evaluate the response to treatment as well as to see the evolution of cognitive and psychiatric comorbidities. As explained above, there are very few randomised trials except for 3 rare epilepsies (infantile spasm syndrome, Dravet syndrome, Lennox-Gastaut syndrome). This has led to the virtual absence of management recommendations, including for the three syndromes mentioned above, where attempts at treatment algorithms have been proposed, although these have not been able to be considered as evidence-based recommendations.
As a result, there is some diversity in the management of rare epilepsies from one centre to another. However, this diversity in management can be an asset in a real-life study. This will make it possible to compare different management methods, both in terms of seizure control and medium-term outcome.
- Conditions
- Epilepsy, West Syndrome, Dravet Syndrome
- Medical subject headings
- Epilepsy, Spasms, Infantile, Epilepsies, Myoclonic
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of decrease in epileptic seizures
rate of decrease in epileptic seizures according to the treatments used based on the seizure calendar kept by the parents as part of the current care.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start11 Dec 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Orphelia Pharma
- Responsible party
- Sponsor
- Investigators
- Blandine DOZIERES, Dr, Study director, Hopital Robert Debré - Assistance Publique Hopitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126914
- Sponsor's protocol ID
- P210776
- Acronym
- EPIRARE
- Status last verified
- Feb 2026
- First submitted
- 22 Oct 2021
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: non available
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents
- ClinicalTrials.gov ID
- NCT05126914
- Acronym / sponsor ID
- EPIRARE / P210776
- Conditions
- Epilepsy, West Syndrome, Dravet Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Orphelia Pharma
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Nov 2021 (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.
Rare epilepsies as a whole account for 20-30% of epilepsies, but knowledge about prognostic factors is currently limited. This means that it is difficult to provide adequate information to families at diagnosis and during follow-up. Prognostic factors are also important for management as they can have an impact on the patient's outcome (time to intervention, choice of one molecule over another, etc.). Finally, few treatments are currently available for these epilepsies. One of the limitations to the development of treatments is the lack of real life data as it is difficult to create reliable primary endpoints such as the rate of patients becoming seizure free naturally compared to a therapeutic intervention.
The aim of this real-life study is to evaluate the response to treatment as well as to see the evolution of cognitive and psychiatric comorbidities. As explained above, there are very few randomised trials except for 3 rare epilepsies (infantile spasm syndrome, Dravet syndrome, Lennox-Gastaut syndrome). This has led to the virtual absence of management recommendations, including for the three syndromes mentioned above, where attempts at treatment algorithms have been proposed, although these have not been able to be considered as evidence-based recommendations.
As a result, there is some diversity in the management of rare epilepsies from one centre to another. However, this diversity in management can be an asset in a real-life study. This will make it possible to compare different management methods, both in terms of seizure control and medium-term outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The population studied in this work will be a pediatric population: from birth to the end of adolescence. There is no limitation in the epileptic syndromes provided that it is a rare epilepsy according to the waxers with a prevalence of 1 in 2000. As mentioned here on several occasions, there is little data on it. efficacy of treatments and the outcome of rare epilepsies. A fairly wide opening on the syndromes to be included will make it possible to collect data without being limited to those which are the subject of the most frequent publications and therefore provide data not available to date.
Key inclusion criteria (3 listed)
- Diagnosis for rare epilepsy (based on ORPHA codes)
- holders of parental authority not opposed
- Be followed in one of the declared centers of the study
Key exclusion criteria (1 listed)
- opposition from the holders of parental authority or the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
rate of decrease in epileptic seizures
Time frame: 5 years
rate of decrease in epileptic seizures according to the treatments used based on the seizure calendar kept by the parents as part of the current care.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No. non available
Related trials for Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 1
Study Designed to Evaluate the Safety, Tolerability, and PK of RAP-219 Formulated as an Long Acting Injectable.
Epilepsy
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.
Blandine DOZIERES, Dr study director
Hopital Robert Debré - Assistance Publique Hopitaux de Paris
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and West Syndrome, run by Assistance Publique - Hôpitaux de Paris at 11 sites in France.
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 1 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Blandine DOZIERES, Dr (0140033667 ext. +33, blandine.dozieres@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of decrease in epileptic seizures (time frame: 5 years). 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 24 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.