Atomoxetine in Patients With Tourette's Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2024-01-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this pilot study is to evaluate the effects of Atomoxetine, a selective noradrenaline reuptake inhibitor, on impulsivity in patients with Tourette's syndrome.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Switching From a Stimulant Medication to Atomoxetine in Children and Adolescents With ADHD

NCT00485875

Attention Deficit Hyperactivity Disorder

COMPLETED PHASE4

A Study of Atomoxetine for Attention Deficit and Hyperactive/Impulsive Behaviour Problems in Children With ASD

NCT00485849

Attention Deficit Hyperactivity Disorder

COMPLETED PHASE4

Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD

NCT00486083

Attention Deficit Hyperactivity Disorder

COMPLETED PHASE3

Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum Disorder

NCT00380692

Autistic Disorder Attention Deficit Disorder With Hyperactivity

COMPLETED PHASE4

Atomoxetine Versus Placebo in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

NCT00191295

Attention Deficit Hyperactivity Disorder

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

High impulsivity characterizes severe forms of Tourette's syndrome, in which motor and vocal tics are associated with various neuropsychiatric disorders as compulsive disorders, difficult to manage and impairing quality of life of patients and their family. Previous preclinical study and clinical studies in attention-deficit hyperactivity disorder and Parkinson's disease demonstrate that atomoxetine, a selective noradrenaline reuptake inhibitor, improves response inhibition in high impulsive individuals. However, there is no suffisant data in Tourette's syndrome. The purpose of this pilot study is to evaluate the effects of Atomoxetine on impulsivity in 10 to 35 years old patients with Tourette's syndrome.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tourette Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients with Tourette's syndrome

Atomoxetine in Patients With Tourette's Syndrome

Group Type EXPERIMENTAL

Atomoxetine

Intervention Type DRUG

Atomoxetine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atomoxetine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* High impulsive patients, aged 10-35 years old, diagnosed for Tourette's syndrome as defined by the DSM-IV, never treated by Atomoxetine
* The use of effective contraception or abstinence for subjects of reproductive age
* Written informed consent

Exclusion Criteria

* Patients with mental retardation, psychotic disorders as schizophrenia, autism spectrum disorders, chronic tics which do not respond to Tourette's syndrome criteria.
* Actual severe depression
* Allergy to one of the constituents
* Severe cardiovascular or cerebrovascular diseases, Pheochromocytoma, uncontrolled hyperthyroidism, closed angle glaucoma
* IMAO treatment discontinued less than 2 months or contra-indicated associated treatment

Minimum Eligible Age

10 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes