NCT04354103

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2022

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
Last Updated

January 23, 2024

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

April 7, 2020

Last Update Submit

January 19, 2024

Conditions

Tourette Syndrome

Keywords

Impulsivity

Outcome Measures

Primary Outcomes (1)

  • Impulsive state

    The primary outcome is the variation of impulsive state (%) before and after chronic administration of atomoxetine, as measured with quantitative tool (CANTAB)

    8 weeks

Secondary Outcomes (1)

  • Cognition, anxiety, depression, severity of tics and compulsive disorders Tolerance

    8 weeks

Study Arms (1)

patients with Tourette's syndrome

EXPERIMENTAL

Atomoxetine in Patients With Tourette's Syndrome

Drug: Atomoxetine

Interventions

AtomoxetineDRUG

Atomoxetine

patients with Tourette's syndrome

Eligibility Criteria

Age10 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospices civils de Lyon

Lyon, France

Location

AP-HP La Pitié Salpêtrière

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

Related Publications (4)

  • Ansquer S, Belin-Rauscent A, Dugast E, Duran T, Benatru I, Mar AC, Houeto JL, Belin D. Atomoxetine decreases vulnerability to develop compulsivity in high impulsive rats. Biol Psychiatry. 2014 May 15;75(10):825-32. doi: 10.1016/j.biopsych.2013.09.031. Epub 2013 Oct 11.

    PMID: 24252357BACKGROUND

  • Chamberlain SR, Del Campo N, Dowson J, Muller U, Clark L, Robbins TW, Sahakian BJ. Atomoxetine improved response inhibition in adults with attention deficit/hyperactivity disorder. Biol Psychiatry. 2007 Nov 1;62(9):977-84. doi: 10.1016/j.biopsych.2007.03.003. Epub 2007 Jul 17.

    PMID: 17644072BACKGROUND

  • Kehagia AA, Housden CR, Regenthal R, Barker RA, Muller U, Rowe J, Sahakian BJ, Robbins TW. Targeting impulsivity in Parkinson's disease using atomoxetine. Brain. 2014 Jul;137(Pt 7):1986-97. doi: 10.1093/brain/awu117. Epub 2014 Jun 3.

    PMID: 24893708BACKGROUND

  • Allen AJ, Kurlan RM, Gilbert DL, Coffey BJ, Linder SL, Lewis DW, Winner PK, Dunn DW, Dure LS, Sallee FR, Milton DR, Mintz MI, Ricardi RK, Erenberg G, Layton LL, Feldman PD, Kelsey DK, Spencer TJ. Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders. Neurology. 2005 Dec 27;65(12):1941-9. doi: 10.1212/01.wnl.0000188869.58300.a7.

    PMID: 16380617BACKGROUND

MeSH Terms

Conditions

Tourette SyndromeImpulsive Behavior

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 21, 2020

Study Start

May 31, 2022

Primary Completion

January 19, 2024

Study Completion

January 19, 2024

Last Updated

January 23, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)