A PET-MRI study of serotoninergic brainstem pathway in patients with Dravet Syndrome - DRAPETONINE

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospices Civils De Lyon

Participant type

Healthy volunteers, Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

4 May 2026 → ongoing

Decision date (initial)

2026-02-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2025-524199-40-00

ClinicalTrials.gov

NCT07013331

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

Comparing the [18F]-MPPF PET brainstem regional distribution of 5HT1A receptors in patients with DS with the one of patients with drug-resistant focal epilepsy

Secondary objectives 6

1. Comparing the [18F]-MPPF PET brainstem regional distribution of 5HT1A receptors in patients with DS with drug-resistant focal epilepsy with the one of healthy subjects
2. Comparison of the cortical BPND of [18F]-MPPF across patients groups (DS and focal epilepsy) and with the one of healthy subjects
3. Evaluating the relation between [18F]-MPPF PET brainstem regional distribution of 5HT1A receptors and inter-ictal respiratory function in patients with DS
4. Comparing brainstem regional volumes on MRI of patients with DS with the one of patients with drug-resistant focal epilepsy
5. Comparing brainstem regional volumes on MRI of patients with DS or with drug-resistant focal epilepsy with the one of healthy subjects
6. Evaluating the relation between the brainstem regional volumes on MRI and inter-ictal respiratory function in patients with DS

Conditions and MedDRA coding

neurology

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 15

1. Patients with Dravet Syndrome: Adult patients (≥ 18 but < 60 years)
2. Patients with Dravet Syndrome: Diagnosis of Dravet syndrome will be confirmed based on medical history, type of seizures, EEG data and results of genetic testing 3. No restriction related to the seizure frequency
3. Patients with Dravet Syndrome: No restriction related to the seizure frequency
4. Patients with Dravet Syndrome: Patient assent and patient (or patient’s legal representative guardianship) who gave its written informed consent to participate to the study
5. Patients with Dravet Syndrome: For women of childbearing potential, use highly effective contraception during study participation.
6. Patients with drug-resistant focal epilepsy: Adult patient (≥ 18 years)
7. Patients with drug-resistant focal epilepsy: Patient suffering from drug-resistant focal epilepsy according to ILAE classification
8. Patients with drug-resistant focal epilepsy: Patient in whom presurgical evaluation is considered
9. Patients with drug-resistant focal epilepsy: No restriction related to the seizure frequency
10. Patients with drug-resistant focal epilepsy: Patient who gave her/his written informed consent to participate to the study
11. Patients with drug-resistant focal epilepsy: For women of childbearing potential, use highly effective contraception during study participation
12. Healthy controls: Adult (≥ 18 years < 50 years)
13. Healthy controls: Without history of neurological disorders, and/or general medical disorders
14. Healthy controls: Subject who gave her/his written informed consent to participate to the study
15. Healthy controls: For women of childbearing potential, use highly effective contraception during study participation

Exclusion criteria 33

1. Patients with Dravet Syndrome: Subject in exclusion period of another study
2. Patients with Dravet Syndrome: MRI contra-indication (presence of metallic elements, claustrophobia, Patients unable to maintain a minimul level of immobility during the imaging acquisition)
3. Patients with Dravet Syndrome: Presence of Vagal Nerve Stimulation
4. Patients with Dravet Syndrome: Patients unable to maintain a minimul level of immobility during the imaging acquisition
5. Patients with Dravet Syndrome: Pregnant women, women in labor or breastfeeding women.
6. Patients with Dravet Syndrome: Severe renal failure (Glomerular filtration rate < 30 ml/min)
7. Patients with Dravet Syndrome: Hypersensitivity to [18F] MPPF
8. Patients with Dravet Syndrome: Persons deprived of their liberty by a judicial or administrative decision
9. Patients with Dravet Syndrome: Persons under psychiatric care
10. Patients with Dravet Syndrome: Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
11. Patients with drug-resistant focal epilepsy: Subject in exclusion period of another study
12. Patients with drug-resistant focal epilepsy: MRI contra-indication (presence of metallic elements, claustrophobia)
13. Patients with drug-resistant focal epilepsy: Presence of Vagal Nerve Stimulation
14. Patients with drug-resistant focal epilepsy: Ongoing serotoninergic treatment, including selective serotonin reuptake inhibitor
15. Patients with drug-resistant focal epilepsy: Pregnant women, women in labor or breastfeeding women.
16. Patients with drug-resistant focal epilepsy: Severe renal failure (Glomerular filtration rate < 30 ml/min)
17. Patients with drug-resistant focal epilepsy: Hypersensitivity to [18F] MPPF
18. Patients with drug-resistant focal epilepsy: Persons deprived of their liberty by a judicial or administrative decision
19. Patients with drug-resistant focal epilepsy: Persons under psychiatric care
20. Patients with drug-resistant focal epilepsy: Persons admitted to a health or social institution for purposes other than research
21. Patients with drug-resistant focal epilepsy: Adults subject to a legal protection measure (guardianship, curatorship)
22. Patients with drug-resistant focal epilepsy: Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
23. Healthy controls: Presence of the symptoms of anxiety and/or depression as defined by a score ≥ 11 at the French version of the Hospital Anxiety and Depression Scale (HADS)
24. Healthy controls: Ongoing treatment with selective serotonin reuptake inhibitor
25. Healthy controls: MRI contra-indication (presence of metallic elements, claustrophobia)
26. Healthy controls: Pregnant women, women in labor or breastfeeding women.
27. Healthy controls: Severe renal failure (Glomerular filtration rate < 30 ml/min)
28. Healthy controls: Hypersensitivity to [18F] MPPF
29. Healthy controls: Persons deprived of their liberty by a judicial or administrative decision
30. Healthy controls: Persons under psychiatric care
31. Healthy controls: Persons admitted to a health or social institution for purposes other than research
32. Healthy controls: Adults subject to a legal protection measure (guardianship, curatorship)
33. Healthy controls: Persons not affiliated to a social security scheme or beneficiaries of a similar scheme

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Comparison of the brainstem BPND of [18F]-MPPF across patients groups (DS and focal epilepsy)

Secondary endpoints 6

1. Comparison of the brainstem BPND of [18F]-MPPF of each patients group (DS and focal epilepsy) with the one of healthy subjects
2. Comparison of the cortical BPND of [18F]-MPPF across patients groups (DS and focal epilepsy) and with the one of healthy subjects
3. aluating the relation between [18F]-MPPF PET brainstem regional distribution of 5HT1A receptors and inter-ictal respiratory function in patients with DS
4. Comparing brainstem regional volumes on MRI of patients with DS with the one of patients with drug-resistant focal epilepsy
5. Comparing brainstem regional volumes on MRI of each patients group (DS and focal epilepsy) with the one of healthy subjects
6. Evaluating the relation between the brainstem regional volumes on MRI and inter-ictal respiratory function in patients with DS

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospices Civils De Lyon

Sponsor organisation

Hospices Civils De Lyon

Address

3 Quai Des Celestins, Bp 2251 Bp 2251

City

Lyon Cedex 02

Postcode

69229

Country

France

Scientific contact point

Organisation

Hospices Civils De Lyon

Contact name

Pr Sylvain RHEIMS

Public contact point

Organisation

Hospices Civils De Lyon

Contact name

Pr Sylvain RHEIMS

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications