A Phase 2 interventional study of 5-ALA (Gliolan) in Drug Resistant Epilepsy, sponsored by Hospices Civils de Lyon. Not yet recruiting at 2 sites in France. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Hospices Civils de Lyon · Phase 2, Interventional, and Other
Among 35 studies in Drug Resistant Epilepsy with a site in France — 16 open to participants now, 17 under way, 1 of them phase 3. Drug Resistant Epilepsy · France.
Among the 35 studies in Drug Resistant Epilepsy with a site in France, this one is the 22nd largest by planned enrollment of the 24 interventional ones that give a count, is one of 5 that started in 2026, is one of 4 in phase 2, reaches primary completion later than 12 of the 16 other live ones, and was the 34th registered.
257 studies on the registry are indexed under Drug Resistant Epilepsy; 108 are open to participants now.
Browse Drug Resistant Epilepsy studies →16 of the 35 studies in Drug Resistant Epilepsy with a site in France are open now. Recruiting first, the newest first:
Assistance Publique Hopitaux De Marseille · Sites in France
Ages 12+
Hospices Civils de Lyon · Sites in France
Ages 18–60 · Healthy volunteers
University Hospital, Strasbourg, France · Sites in France
Ages 5–25
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18–65
Assistance Publique Hopitaux De Marseille · Sites in France
Ages 9+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 66 Drug Resistant Epilepsy studies recruiting now, 26 (39%) set no upper age limit and 39 (59%) stop at 75 or younger; 25 take children under 18; 6 take healthy volunteers.
This study: 3 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
35 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 8 · Phase 3 8
First in 2005; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 5 is below the median of 30 across 202 interventional studies indexed under Drug Resistant Epilepsy.
Median enrollment 82 across the 24 interventional studies, 110 across the 11 observational. Of the 14 that completed or were terminated, 5 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 35 have an industry lead sponsor. The 10 most frequent:
Hospices Civils de Lyon is the lead sponsor of 1,867 studies on the registry; 448 are open to participants now.
Hospices Civils de Lyon has 5 studies filed under Drug Resistant Epilepsy — fewer than ten, so there is no comparison to draw.
5 of the studies in Drug Resistant Epilepsy with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06132893Phase 3Biohaven Therapeutics Ltd.A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy | 2026-12 |
| NCT06443463Biohaven Therapeutics Ltd.Long-term Safety and Tolerability of BHV-7000 | 2026-12 |
| NCT06334952Assistance Publique Hopitaux De MarseilleEfficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic | 2026-12-18 |
| NCT06138808Duke University5-SENSE Score Validation Study | 2027-01 |
| NCT07898397University Hospital, Strasbourg, FranceLong-Term Epilepsy Outcomes in Children With a History of Perinatal Stroke | 2027-02-28 |
Add all 5 to your calendar (.ics) → With an account.
Among the 35 studies in Drug Resistant Epilepsy with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Epilepsy is one of the most common neurological disorders, with one of the highest morbidity rates of all diseases. Despite the development of new anticonvulsant drugs, around a third of patients suffer from drug-resistant epilepsy (RPE). The onset of RPE can be lengthy, prolonging the period during which affected patients live with seizures that have a negative impact on their quality of life. Epilepsy surgery can be a curative treatment, and can enable anticonvulsant medication to be discontinued, optimizing quality of life and cognitive development. In addition, as it has been shown that the prolonged duration of epilepsy prior to surgery has an impact on the occurrence of postoperative seizures, early surgery is increasingly being considered. Focal cortical dysplasia (FCD) is the leading cause of focal lesional epilepsy and is generally drug-resistant. Good postoperative seizure results after surgical resection are strongly linked to complete resection of the dysplastic tissue. Consequently, accurate localization and precise delineation of FCD lesions are crucial during surgery. Currently, the extent of surgical resection is based primarily on preoperative examination, as the macroscopic appearance of dysplastic tissue does not differ from normal cortex. The various intraoperative techniques available to improve the quality of excision (neuronavigation, ultrasound, intraoperative MRI and intraoperative guidance by fluorescence microscopy) all have their limitations. In this context, new intraoperative tools are needed to help the neurosurgeon delineate lesions during surgery. Intraoperative fluorescence spectroscopy is used for surgical guidance of gliomas and other brain pathologies, and has demonstrated its ability to characterize pathological tissues. DCFs exhibit metabolic differences that can also be detected by 5-amino-levulinic acid (5-ALA)-induced protoporphyrin IX (PpIX) fluorescence intraoperatively. Indeed, in some patients who underwent surgery after a diagnosis of glioma, fluorescence was observed even though histological analysis classified the excised tissue as DCF. What's more, glioma and DCF share a common feature: the mitochondria of affected cells are deficient in complex IV. Cytochrome c oxidase (CCO) is largely involved in mitochondrial complex IV, and NAD is a central metabolite involved in redox reactions within cells. Both metabolites (CCO and NAD) can be visualized intraoperatively by optical and fluorescence spectroscopy.
FLUOFOCODYS is a prospective, non-comparative, single-center, human drug pilot clinical trial. 5 patients will be included.
Primary objective of FLUOFOCODYS study is to measure the fluorescence of biomarkers of focal epileptic lesions by intraoperative fluorescence spectroscopy.
The secondary objectives are as follows:
The hypothesis of this project is that intraoperative fluorescence spectroscopy could robustly measure 5-ALA-induced protoporphyrin IX fluorescence in FCD and could ultimately aid FCD surgery. Thus, to understand intraoperative biomarker fluorescence spectroscopy in DCF, preoperative MRI and postoperative histology are crucial. This will enable MRI-informed intraoperative fluorescence spectroscopy. These comparative measurements will be completed with SpiderMass technology (metabo-lipidomic mass spectrometry). The effectiveness of intraoperative tools could therefore be assessed prior to surgery, which could have an impact on the therapeutic decision to proceed with surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children and adults with drug resistant epilepsy, related to a probable FCD and with surgical indication validated by the epileptic multi-disciplinary staff meeting will receive the study treatment (5-ALA) orally at a dose of 20mg/kg
Drug: 5-ALA (Gliolan)
Patients will be given 5-ALA (20 mg per kilogram body weight) before the surgery, between 2 and 4 hours before anaesthesia.
Concentration of fluorescent compound (in mol/L) during the chirurgical intervention on the extracted tissue sample of FCD
Measure of biomarkers fluorescence of focal epileptic lesion by intraoperative fluorescence spectroscopy.
Time frame: Day 0
FCD volume in mm3 on standard MRI
Compare FCD volume between High Resolution-MultiModal-MRI and standard MRI.
Time frame: 60 days before Day 0 (=surgery)
FCD volume in mm3 on High Resolution MM- MRI
Compare FCD volume between High Resolution-MultiModal-MRI and standard MRI.
Time frame: Day 0 (=surgery)
Index kappa concordance of the volume in mm3 of focal cortical dysplasia measured by standard MRI
Evaluation of the concordance of FCD measurements between HR-MM-MRI and standard MRI
Time frame: 60 days before day 0
Index kappa concordance of the volume in mm3 of focal cortical dysplasia measured by HR MM-MRI
Evaluation of the concordance of FCD measurements between HR-MM-MRI and standard MRI
Time frame: Day 0
Concentration measured by fluorescence spectroscopy on extracted tissue sample of FCD
Evaluation of correlation between fluorescence spectroscopy measurements and Spidermass measurements on extracted tissue sample of FCD.
Time frame: Day 0
Relative concentration of molecular species measured by SpiderMass on extracted tissue sample of FCD
Evaluation of correlation between fluorescence spectroscopy measurements and Spidermass measurements on extracted tissue sample of FCD.
Time frame: Day 0
Number of adverse events
Description of any Adverse Events that have occurred after the experimental treatment until end of study participation
Time frame: From the enrollment to day 1
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Oral Aminolevulinic Acid Hydrochloride