Multicentre, randomised, double-blinded, placebo-controlled trial of efficacy of amoxicilline/clavulanic acid in patients affected by tic disorder colonized by GAS. No-proft stidy.

Phase 4

Completed

• Conditions: Tourette Disorder; Tourettes; 10012562

• Registration Number: NL-OMON53389
• Lead Sponsor: Azienda Universiaria Policlinico Umberto I di Roma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

Participant and parents willing and able to give informed consent for participation in the study * Male or Female, aged 3-16. * Diagnosis of Tourette Syndrome or another chronic tic disorder according to DSM IV-TR criteria. * Evidence of GAS colonization at any visit of EMTICS Longitudinal Course Study. * Either no current psychotropic medication or on stable anti-tic medication for at least 2 months before the enrolment in the trial. Able (in the Investigators opinion) and willing to comply with all study requirements.

Exclusion Criteria

The participant may not enter the study if ANY of the following apply: * Children and/or parents are unable to understand and comply with protocol * Any antibiotic treatment for any reason during the last month before enrolment in the trial. * Clinical manifestations of pharyngitis or other streptococcal infections at moment of enrolment in the trial. * Known or suspected hypersensitivity to penicillin or other *-lactam antibacterials, a history of amoxicillin-clavulanate-associated cholestatic jaundice or hepatic dysfunction. * Known and/or suspected renal or hepatic impairment (due to the potential for drug-related toxicity in patients with such a condition). * Scheduled elective surgery or other procedures requiring general anaesthesia during the study. * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant*s ability to participate in the study. Participants who have participated in another research study involving an investigational product in the past 12 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study outcome is tic severity as measured by the Yale Global Tic<br /><br>Severity Scale (YGTSS). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Premonitory Urge for Tics Scale (PUTS).<br /><br>2) Symptoms of OCD as measured by the Children*s Yale Brown<br /><br>Obsessive-Compulsive Scale (CYBOCS).<br /><br>3) Symptoms of autism spectrum disorders, ADHD, and internalising and<br /><br>externalising psychopathology<br /><br>a. Social Communication Questionnaire (SCQ).<br /><br>b. Swanson, Nolan, and Pelham, version IV (SNAP-IV) rating scale.<br /><br>c. Strengths and Difficulties Questionnaire (SDQ).<br /><br>4) Moderators<br /><br>- Prenatal and perinatal adversities as assessed by parental self-report.<br /><br>- Psychosocial stress measured using the Perceived Stress Scale.<br /><br>- Cortisol levels in hair as biomarker of retrospective chronic stress.<br /><br>- Microbiological typing of bacterial GAS population<br /><br>- Anti-Streptococcal Immune Response </p><br>