E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
High impulsive Tourette’s syndrome patients |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042808 |
E.1.2 | Term | Syndrome Gilles de la Tourette |
E.1.2 | System Organ Class | 100000004850 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main goal of this study is to assess the effect of 8 weeks of treatment with atomoxetine, a selective recapture noradrenaline inhibitor, on impulsive state measured with the Stop signal task (Cambridge Cognition). |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to assess the safety and therapeutic effect of 8 weeks of treatment with atomoxetine on other forms of impulsivity (cognitive impulsivity), cognition, mood and severity of tics.
|
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Evaluation of the effect of Atomoxetine on impulsive state of High impulsive Tourette’s patients. version n°1 du 12.11.2019
In a sub-study, we propose to establish an anatomo-clinical correlation about the effect of atomoxetine on motor impulsive state. Regarding to previous studies, we predict an activation of the right inferior frontal gyrus.
Principal exclusion criteria Contraindication to cerebral MRI (claustrophobia, pacemaker, implantable defibrillator, neurostimulator, implanted electronic equipment, cohesive implants, ocular or cerebral ferromagnetic foreign bodies, implanted metallic equipment: stents, coils, valves, prosthesis, etc.) |
|
E.3 | Principal inclusion criteria |
Patients: Tourette’s patients from 10 to 35 years old diagnosed according to the criteria of DSM-V, with high impulsive trait, and who freely consent to this study
Healthy subjects, of normal development, free from any neuropsychiatric pathology, matched 1:1 in age and sex to the patients recruited in this study. |
|
E.4 | Principal exclusion criteria |
Other psychiatric disease of the axis I of DSM-IV, severe depression, allergic reactions to chemical coumpounds of the treatment or medical contraindications of atomoxetine, concommitent treatments contraindicated with atomoxetine (IMAO) interrupted from less tha 2 weeks or Clonidine or Methyphenidate interrupted from less than 1 month |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Stop Signal Reaction Time variation (ms) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
10 weeks = Visit 6 (J70) compared to V1 (J0) |
|
E.5.2 | Secondary end point(s) |
1- Efficacy : compared to baseline, effect of 8 weeks of treatement with atomoxetine on : -percentage of commission errors on the Stop Signal Task (SST) -Cognitive impulsivity in the Cambridge Gambling Task (CGT) (delay aversion, bit, deliberation time, risk taking, risk adjustment, decision making quality) -% antisaccades measured with electro-oculograph SURICOG (Eye Brain T2) -Stroop -Rey figure -Severity of tics, measured with YGTSS and Rush video scale -Severity of TOCs, measured with YBOCS -Other compulsive disorders -Severity of anxiety measured with STAI or depression with BDI
2/ tolerance
3/ For functional MRI sub-study (only patients recruted in CHU de Poitiers) : Establish an anatomo-clinical correlation in functional MRI of the effect of atomoxetine in impulsive state measured with the Stop Signal Task.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
10 weeks = Visit 6 (J70) compared to V1 (J0) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 28 |
E.8.9.1 | In the Member State concerned days | |