Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
1
Tourette disorder
To determine the correlative links between the availability of serotonergic 5-HT2A receptors and the variations in impulsivity measured in adults with Tourette's syndrome during treatment begin in the routine care.
Key facts
- Sponsor
- Hospices Civils De Lyon, Hospices Civils De Lyon
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 5 Sep 2024 → ongoing
- Decision date (initial)
- 2023-10-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- La fondation de france
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To determine the correlative links between the availability of serotonergic 5-HT2A receptors and the variations in impulsivity measured in adults with Tourette's syndrome during treatment begin in the routine care.
Secondary objectives 3
- To determine the correlative links between the availability of serotoninergic 5-HT2A receptors and the variations of each of the other psycho-behavioural data measured in adults with Tourette's syndrome during treatment begin in the routine care
- To determine the correlative links between cerebral activity measured by fMRI and variations in impulsivity measured in adults with Tourette's syndrome during treatment begin in the routine care
- To determine the correlative links between cerebral activity measured by fMRI and the variations of each of the other psycho-behavioral data measured in adults with Tourette's syndrome during treatment begin in the routine care.
Conditions and MedDRA coding
Tourette disorder
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10018271 | Gilles de la Tourette's disorder | 10010331 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Administration of a PET radiotracer A highly selective 5-HT2A receptor ligand ([18F]-altanserin) will be injected to patients before each PET scan. The IV injection in the arm (via a cathether) will be performed in continue during a period of 2 hours in the imaging centre (CERMEP) before the acquisition. The dose will be 2,6 MBq/kg 10 % depending the prescription of the nuclear medicine.
Patients will be evaluated twice, one time free of neuroleptic treatment and a second time during stable chronic treatment by neuroleptic.
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Male or Female
- Diagnosed with a Tourette Disorder following the DSM-5
- Age between 18-65 years
- Member of a social security scheme in France
- Freely-given informed consent to participate to this study (written form)
- With a current treatment by aripiprazole already scheduled
- With Tics compatible with TEP/fMRI exams
- Having (for women only) effective contraception throughout participation in the study.
Exclusion criteria 9
- Male or Female
- A serious not controlled psychiatric comorbidity
- A serious, evolving or debilitating pathology with a potential influence on the study
- Drug-taking with serotonergic effects (e.g., amphetamine, cocaine, MDMA, SSRIs, mianserin)
- Contraindication for fMRI and PET (e.g., pacemaker, ferromagnetic implant, claustrophobia)
- Women breastfeeding
- Protected or restricted person (administratively or in judicial terms)
- Participants to another study with radiations or radiotracers since less of one year, participants to a concomitant study
- Do not speak french
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Correlation coefficients between changes in the binding potential (BPND) of [18F]-altanserin measured voxel-by-voxel in the whole brain and the evolution of scores BIS11 in TD patients.
Secondary endpoints 3
- Correlation coefficients between changes in the binding potential (BPND) of [18F]-altanserin measured voxel-by-voxel in the whole brain and the evolution of other clinical scores and task performance of TD patients.
- Correlation coefficients between changes in the BOLD signal measured voxel-by-voxel in the whole brain and the evolution of scores BIS11 in TD patients.
- Correlation coefficients between changes in the BOLD signal measured voxel-by-voxel in the whole brain and the evolution of other clinical scores and task performance of TD patients.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10479206 · Product
- Active substance
- [18F-ALTANSERIN
- Pharmaceutical form
- INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 300 MBq megabecquerel(s)
- Max total dose
- 300 MBq megabecquerel(s)
- Max treatment duration
- 300 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- HOSPICES CIVILS DE LYON
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 1
SCP13257574 · ATC
- Active substance
- Aripiprazole
- Route of administration
- ORAL USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 15 mg milligram(s)
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05AX12 — ARIPIPRAZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- indication
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 THOBOIS Stéphane
Public contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Pr THOBOIS Stéphane
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
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-09-05 | 2024-09-24 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-05 | France | Acceptable with conditions 2023-10-23
|
2023-10-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-22 | France | Acceptable 2024-02-14
|
2024-02-15 |