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Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled Epilepsy

Study acronym: EPI-RISK
StatusRecruiting
PhaseNot applicable
Started2024-04-16
View on ClinicalTrials.gov ↗

Amendment history

2026-07-09
Study Status, Oversight, Contacts/Locations v5
Study sites1→2
2025-09-29
Study Status, Oversight, Eligibility v4
Eligibility criteria+77 characters
Inclusion Criteria: Patient between 18 and 4060 years old Patient with poorly controlled epilepsy (persiste [...] ures evolving for more than a year despite proper treatment) or patient seizure-free for over a year but for whom therapeutic patient education (TPE) would be beneficial according to the investigator.. Patient agreeing to participate in a therapeutic education [...] sy program Patients with major cognitive impairment Patient deprivedunder of liberty by courtguardianship or administrative decision, subject to a legal protection measure(safeguard (guardianshipof or curatorshipjustice) Pregnant or [...]
2024-08-08
Study Status, Eligibility v3
Primary completion date2026-10-01→2028-04-16
Completion date2027-03-01→2028-04-16
Eligibility criteria+27 characters
[...] n a therapeutic education program (TPE) Exclusion Criteria: Epileptic patient with an intellectual deficit Epileptic patient who has already benefited from a TPE epilepsy program Patients with major cognitive impairment Patient deprived of liberty by court or administrative decis [...] to a legal protection measure (guardianship or curatorship) Pregnant or breast-feeding women Failure to obtain written informed consent after a reflectio [...]
2024-04-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-02-01→confirmed 2024-04-16
Study sitesdetails revised at 1 of 1 site
2024-01-22
Study Identification, Study Status, Study Description, Arms and Interventions v1
InterventionsControl group "Usual management" (Procedure), Experimental group (Procedure)→Risk prevention session (Procedure), Usual Therapeutic Patient Education (TPE) management (Procedure)
Study description+15 characters
The study will be proposed to patients with uncontrolled epilepsy (n=74) aged 18 to 40. WeThe investigators will evaluate 3 months after the last therapeutic patient s [...]
Study title-31 characters
Specific Risk Prevention Program and Therapeutic Patient Education Program on the Risk Behaviors of Patients With Uncontrolled Epilepsy
2023-12-29
Original filing
Pilot, controled, randomized study aiming to evaluate a plan for the prevention of risks related to epilepsy, 3 months after the last therapeutic patient education session. Two groups of patients will be compared: group "intervention" (consultation with the neurologist then a psychologist followed by a session dedicated to risk prevention ("Recognize and Manage risks") integrated into usual Therapeutic Patient Education (TPE) versus "control" group (usual consultations with the neurologist and usual TPE). 37 subjects per group will be included in this study.
Trial Details
NCT Number NCT06202196
Lead Sponsor University Hospital, Montpellier
Conditions Epilepsy
Enrollment 74 participants
Start Date 2024-04-16
Primary Completion 2028-04-16 (estimated)
Study Completion 2028-04-16 (estimated)
Updated on ClinicalTrials.gov 2026-07-13