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Atomoxetine in Patients With Tourette's Syndrome (ATO-TS)

P

Poitiers University Hospital

Status and phase

Terminated
Phase 2

Conditions

Tourette Syndrome

Treatments

Drug: Atomoxetine

Study type

Interventional

Funder types

Other

Identifiers

NCT04354103
2019-004455-36

Details and patient eligibility

About

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.

Full description

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.

Enrollment

5 patients

Sex

All

Ages

10 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

patients with Tourette's syndrome
Experimental group
Description:
Atomoxetine in Patients With Tourette's Syndrome
Treatment:
Drug: Atomoxetine

Trial contacts and locations

3

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Central trial contact

Jean Luc HOUETO, MD, PhD; Solene ANSQUER, MD, PhD

Data sourced from clinicaltrials.gov

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