NCT07507240

Brief Summary

Epilepsy is a chronic condition affecting approximately 600,000 people in France. Epilepsy treatment relies on antiepileptic drugs, the effectiveness of which depends on adherence to medication schedule, with missed doses increasing the risk of seizures. As with any chronic illness, epilepsy presents a significant challenge in terms of treatment adherence. Furthermore, despite good medication adherence, 30% of patients remain drug-resistant. Therefore, the aim is to create a remote monitoring program, supported by a nurse, lasting six months after the introduction of a new antiepileptic drug, to support the patient until their next appointment with a neurologist. This system would optimize and secure the care pathway during treatment changes by improving the detection of side effects and/or a resurgence of seizures requiring medication adjustments.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026May 2028

First Submitted

Initial submission to the registry

March 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

March 27, 2026

Last Update Submit

March 27, 2026

Conditions

Epilepsy

Keywords

epilepsyremote monitoringepilepsy treatment

Outcome Measures

Primary Outcomes (1)

  • Describe the evolution of therapeutic adherence

    Measurement of the Mascard scale score in 2 groups of patients benefiting or not from the new care and support pathway.

    6 months after the inclusion

Secondary Outcomes (5)

  • Evolution of Quality of Life between baseline and 6 months

    6 months after the inclusion

  • Description of the care pathway between baseline and 6 months

    6 months after the inclusion

  • Description of patient satisfaction with their medical care

    6 months after the inclusion

  • Evaluation of patient acceptability of remote monitoring

    6 months after the inclusion

  • Evaluation of satisfaction with the use of remote monitoring by the healthcare team

    6 months after the inclusion

Study Arms (2)

Patients with remote monitoring

EXPERIMENTAL

Patients who will benefit from remote monitoring to support them in their changes to antiepileptic treatment

Other: Remote monitoring trainingOther: Therapeutic support with a nurseDiagnostic Test: Questionnaires for the two groupsOther: Satisfaction questionnaire for the group with remote monitoring

Patients without remote monitoring

ACTIVE COMPARATOR

Patients who will receive standard care without remote monitoring as part of a change in anti-epileptic treatment

Other: Description of the standard care pathwayDiagnostic Test: Questionnaires for the two groups

Interventions

Remote monitoring trainingOTHER

Training in the care pathway via remote monitoring software

Patients with remote monitoring
Description of the standard care pathwayOTHER

Description of the standard care pathway with the nurse

Patients without remote monitoring
Therapeutic support with a nurseOTHER

Therapeutic support with a nurse who ensures the patient's adherence to remote monitoring at 1 month and 3 months

Patients with remote monitoring
Questionnaires for the two groupsDIAGNOSTIC_TEST

Quality of life questionnaires at baseline and at 6 months

Patients with remote monitoringPatients without remote monitoring
Satisfaction questionnaire for the group with remote monitoringOTHER

Satisfaction questionnaire for the group with remote monitoring at 6 months

Patients with remote monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of epilepsy by a neurologist
  • Patient requiring the introduction of anti-epileptic medication as an add-on to their usual treatment or as a replacement for their current treatment(s)
  • Access to a reliable internet connection and a compatible device for remote monitoring (smartphone, tablet, computer)
  • Ability to understand and use remote communication technologies

You may not qualify if:

  • Presence of concurrent neurological or psychiatric disorders affecting the ability to use remote monitoring.
  • Presence of a progressive neurological disease, including degenerative CNS disease, or a progressive tumor.
  • Change in treatment for pregnancy preparation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cerebral electrophysiology, epilepsy and sleep, Purpan Hospital, Place du Docteur Baylac

Toulouse, Non, 31059, France

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Marie DENUELLE, MD

CONTACT

05 61 77 94 24denuelle.m@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 2, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations

FR(1)