SeizuresOPERANCT05772429
Long-Term Follow-Up of a Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting
An observational study of Seizures, run by Jazz Pharmaceuticals at 29 sites in France.
Trial summary
This is a multi-center, non-interventional and prospective study of patients receiving Epidyolex as part of standard clinical practice in France. The study will state an overview of patient characteristics and clinical history (including age, sex, diagnosis, duration of epilepsy, predominant seizure type, previous… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Seizures
- What is being tested?
- Epidiolex
- Type of treatment
- Pill or oral medicine
- How many people
- 158 participants
- Where
- 29 sitesFrance
- Study dates
- 17 Apr 2023to 25 Aug 2026
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants for whom Epidyolex is prescribed according to the approved therapeutic indications and criteria of the summary of product Characteristics (SmPC). Participants will be recruited from approximately 15 facilities specializing in treating rare epilepsies in France.
Who may be able to join
- Individuals for whom treatment with Epidyolex has been initiated by a physician with experience in the treatment of epilepsy.
- The participant and/or parent(s)/legal representative is willing and able to give informed consent/assent for participation in the study.
Who cannot join
- Previously initiated with Epidyolex before the start of the study (especially during the French early access program (EAP)).
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
France29 sites
CHU Amiens-service adulte
Amiens, 80054
CHU Amiens-service enfant
Amiens, 80054
CHU Angers - service adulte
Angers, 49100
CHU Angers - service enfant
Angers, 49100
CHU Bordeaux - service adulte
Bordeaux, 33000
CHU Bordeaux,neuropédiatrie
Bordeaux, 33000
GH Est - Hôpital Femme Mère Enfant
Bron, 69500
HCL - Lyon - service adulte
Bron, 69677
CHU Dijon - service neurophysiologie clinique
Dijon, 21000
CHU Grenoble - service adulte
Grenoble, 38700
CHU Grenoble - service enfant
Grenoble, 38700
APHP Kremlin Bicetre - service enfant
Le Kremlin-Bicêtre, 94270
CHU Lille - service enfant
Lille, 59037
Hôpital Salengro - service adulte
Lille, 59037
APHM - Marseille - service adulte
Marseille, 13005
Hôpital de la Timone - service enfant
Marseille, 13005
CHU Nancy - service adulte
Nancy, 54000
CHU Nancy - service enfant
Nancy, 54000
APHP Pitié Salpetriere- service adulte
Paris, 75013
APHP Robert Debré - service enfant
Paris, 75019
APHP Necker - service enfant
Paris, 75743
CHU Rennes - service adulte
Rennes, 35000
CHU Rennes - service enfant
Rennes, 35200
CHU Strasbourg - service enfant
Strasbourg, 67200
Hôpital de Hautepierre - service adulte
Strasbourg, 67200
CHU Toulouse - service adulte
Toulouse, 31059
CHU Toulouse - service enfant
Toulouse, 31059
Hôpital Bretonneau - service adulte
Tours, 37000
Hôpital Clocheville - service enfant
Tours, 37044
About this study
Official title: Long-term Follow-up of a Multicentre, Non-interventional, Prospective Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting
This is a multi-center, non-interventional and prospective study of patients receiving Epidyolex as part of standard clinical practice in France. The study will state an overview of patient characteristics and clinical history (including age, sex, diagnosis, duration of epilepsy, predominant seizure type, previous medications, current co-medications and Epidyolex dose), and an evaluation of retention rates, safety profile, seizure activity, changes in executive function and quality of life measured in a 2-year follow-up period.
- Conditions
- Seizures
- Being tested
- Epidiolex
- Keywords
- Seizure Therapy, Cannabidiol, GW CBD, Epidyolex, Epidiolex, Jazz CBD
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpidiolexDrug
Also called Cannabidiol, Epidyolex
Administered as an oral solution
| Study group | Role | What they receive |
|---|---|---|
| Epidyolex | Participants will receive Epidyolex in accordance with their routine clinical practice as prescribed by their physician. Receives: Drug: Epidiolex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate Percentage After Initiation of Treatment With Epidyolex
Retention rate will be measured through assessing the frequency of seizures and the length of time on treatment before a seizure event.
Measured: Up to 24 months post-dose.
Secondary outcomes (16)
Percent Change From Baseline in Seizure Frequency (Average Per 28 Days)
Measured: Up to 24 months post-dose.
50% Responder Rate
Measured: Up to 24 months post-dose.
75% Responder Rate
Measured: Up to 24 months post-dose.
100% Responder (Seizure Freedom) Rate
Measured: Up to 24 months post-dose.
Number of Seizure-Free Days (Average Per 28 Days)
Measured: Up to 24 months post-dose.
Longest Duration of Seizure-Free Days in the Last 28 Days
Measured: Up to 24 months post-dose.
Change From Baseline in Behavior Rating Inventory of Executive Function, Preschool Version (BRIEF-P) Score in Participants Aged ≤5 Years
The BRIEF-P is a 63-item questionnaire which consists of a single Rating Form used by parents, teachers, and day care providers to assess a child's executive functions within the context of their everyday environments--home and preschool. High scores obtained on the BRIEF-P suggest a higher level of dysfunction in a specific domain of executive functions. The BRIEF rating scores is an ordinal set of a technically summarized degree of disorder in functionality: Never = 1 (Minimum), Sometimes = 2 and Often = 3 (Maximum).
Measured: Baseline; Up to 24 months post-dose.
Change From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Score in Participants Aged 6 to 18 Years
BRIEF is an 86-item questionnaire used to assess the executive function behaviors at home and at school for children and adolescents ages 5-18. High scores obtained on the BRIEF suggest a higher level of dysfunction in a specific domain of executive functions. The BRIEF rating scores is an ordinal set of a technically summarized degree of disorder in functionality: Never = 1 (Minimum), Sometimes = 2 and Often = 3 (Maximum).
Measured: Baseline; Up to 24 months post-dose.
Change From Baseline in Behavior Rating Inventory of Executive Function, Adult Version (BRIEF- A) Score in Participants Aged >18 Years
BRIEF-A is a patient-reported scale to measure various aspects of adult executive functioning and self-regulation in the person's everyday environment. It is a 75-item questionnaire that participants rate on a 3-point Likert scale (1 = behavior is never observed to 3 = behavior is often observed). Higher scores indicate greater impairment in executive functioning.
Measured: Baseline; Up to 24 months post-dose.
Modal Dose of Epidyolex Administered to Participants
Measured: Up to 24 months post-dose.
Maximum Dose of Epidyolex Administered to Participants
Measured: Up to 24 months post-dose.
Change from Baseline in Average Daily Dosage of Concomitant Anti-Epileptic Drugs (AEDs) and Other Medicines
Measured: Up to 24 months post-dose.
Use of Rescue Medication Per Month
A month is defined as 28 days.
Measured: Up to 24 months post-dose.
Physician Global Clinical Impression of Change (PGIC) Score
The PGIC comprises the following question: "Please assess the change in the patient's general functional abilities since enrollment," scored on a seven-point scale from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores on the scale indicate a better quality of life.
Measured: Up to 24 months post-dose.
Caregiver Global Impression of Change (CGIC) Score
The CGIC comprises of the following question: "Since your child started treatment, please assess the status of your child's overall condition (comparing their condition now to their condition before treatment)," scored on a seven-point scale from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores on the scale indicate a better quality of life.
Measured: Up to 24 months post-dose.
Change from Baseline in Health Utility Index Mark II (HUI-2) Score
The HUI-2 is a generic measure of health status and health-related quality of life. There are 15 questions in the questionnaire with 1-week recall completed by the caregiver. Answers to the questionnaire are mapped into a classification system of 7 sets of utility scores (sensation, mobility, emotion, cognition, self-care, pain, and fertility) with a scoring scale of a minimum score of 0.00 (lack of functional capacity or most disabled) to a maximum of 1.00 (full function or no disability). A higher score indicates a better outcome.
Measured: Up to 24 months post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start17 Apr 2023
- Primary completion25 Aug 2026
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe 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
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772429
- Sponsor's protocol ID
- GWEP20125
- Acronym
- OPERA
- Status last verified
- Nov 2026
- First submitted
- 6 Mar 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of a Multicentre, Non-interventional, Prospective Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting
- ClinicalTrials.gov ID
- NCT05772429
- Acronym / sponsor ID
- OPERA / GWEP20125
- Conditions
- Seizures
- Keywords
- Seizure Therapy, Cannabidiol, GW CBD, Epidyolex, Epidiolex, Jazz CBD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 25 Aug 2026 (actual)
- Study completion
- 25 Aug 2026 (actual)
- First posted
- 16 Mar 2023 (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.
This is a multi-center, non-interventional and prospective study of patients receiving Epidyolex as part of standard clinical practice in France. The study will state an overview of patient characteristics and clinical history (including age, sex, diagnosis, duration of epilepsy, predominant seizure type, previous medications, current co-medications and Epidyolex dose), and an evaluation of retention rates, safety profile, seizure activity, changes in executive function and quality of life measured in a 2-year follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidyolex | – | Drug: EpidiolexParticipants will receive Epidyolex in accordance with their routine clinical practice as prescribed by their physician. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants for whom Epidyolex is prescribed according to the approved therapeutic indications and criteria of the summary of product Characteristics (SmPC). Participants will be recruited from approximately 15 facilities specializing in treating rare epilepsies in France.
Key inclusion criteria (2 listed)
- Individuals for whom treatment with Epidyolex has been initiated by a physician with experience in the treatment of epilepsy.
- The participant and/or parent(s)/legal representative is willing and able to give informed consent/assent for participation in the study.
Key exclusion criteria (1 listed)
- Previously initiated with Epidyolex before the start of the study (especially during the French early access program (EAP)).
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 |
|---|---|---|
| EpidiolexAlso: Cannabidiol, EpidyolexAdministered as an oral solution | Drug | Epidyolex |
Primary outcome
Retention Rate Percentage After Initiation of Treatment With Epidyolex
Time frame: Up to 24 months post-dose.
Retention rate will be measured through assessing the frequency of seizures and the length of time on treatment before a seizure event.
16 secondary outcomes
Percent Change From Baseline in Seizure Frequency (Average Per 28 Days)
Time frame: Up to 24 months post-dose.
50% Responder Rate
Time frame: Up to 24 months post-dose.
75% Responder Rate
Time frame: Up to 24 months post-dose.
100% Responder (Seizure Freedom) Rate
Time frame: Up to 24 months post-dose.
Number of Seizure-Free Days (Average Per 28 Days)
Time frame: Up to 24 months post-dose.
Longest Duration of Seizure-Free Days in the Last 28 Days
Time frame: Up to 24 months post-dose.
Change From Baseline in Behavior Rating Inventory of Executive Function, Preschool Version (BRIEF-P) Score in Participants Aged ≤5 Years
Time frame: Baseline; Up to 24 months post-dose.
Change From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Score in Participants Aged 6 to 18 Years
Time frame: Baseline; Up to 24 months post-dose.
Change From Baseline in Behavior Rating Inventory of Executive Function, Adult Version (BRIEF- A) Score in Participants Aged >18 Years
Time frame: Baseline; Up to 24 months post-dose.
Modal Dose of Epidyolex Administered to Participants
Time frame: Up to 24 months post-dose.
Maximum Dose of Epidyolex Administered to Participants
Time frame: Up to 24 months post-dose.
Change from Baseline in Average Daily Dosage of Concomitant Anti-Epileptic Drugs (AEDs) and Other Medicines
Time frame: Up to 24 months post-dose.
Use of Rescue Medication Per Month
Time frame: Up to 24 months post-dose.
Physician Global Clinical Impression of Change (PGIC) Score
Time frame: Up to 24 months post-dose.
Caregiver Global Impression of Change (CGIC) Score
Time frame: Up to 24 months post-dose.
Change from Baseline in Health Utility Index Mark II (HUI-2) Score
Time frame: Up to 24 months post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizures, run by Jazz Pharmaceuticals at 29 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 2 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: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate Percentage After Initiation of Treatment With Epidyolex (time frame: Up to 24 months post-dose.). 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 3 Nov 2026.