Multicentre, randomised, double-blinded, placebo-controlled trial of efficacy of antibiotic therapy in patients affected by tic disorder and with group A streptococcal colonization, No-profit study.
- Conditions
- Chronic tic disorderMedDRA version: 16.1Level: LLTClassification code 10043834Term: Tic disorder, unspecifiedSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]
- Registration Number
- EUCTR2012-002430-36-NL
- Lead Sponsor
- AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 72
• Participant and/or 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 72
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 ß-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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Test the hypothesis that antibiotic treatment of GAS colonisation compared to placebo is associated with a larger reduction of tic and associated neuropsychiatric symptoms in the short-term (1 month) in patients with a tic disorder colonised by GAS.;Secondary Objective: Test the hypothesis that antibiotic treatment of GAS colonisation is superior to placebo in the long-term (1 year) reduction of tic and associated neuropsychiatric symptoms in patients with a tic disorder colonized by GAS. Investigate the influence of possible moderators on treatment outcome. Investigate the effects of antibiotic treatment on patient’s immune responses to GAS antigens.;Primary end point(s): Yale Global Tic Severity Scale (YGTSS) Score;Timepoint(s) of evaluation of this end point: 1 month
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Premonitory Urge for Tics Scale (PUTS) 2) Children’s Yale Brown Obsessive-Compulsive Scale (CYBOCS) 3) Symptoms of autism spectrum disorders, ADHD, and internalising and externalising psychopathology a. Social Communication Questionnaire (SCQ). b. Swanson, Nolan, and Pelham, version IV (SNAP-IV) rating scale. c. Strengths and Difficulties Questionnaire (SDQ). 4) Prenatal and perinatal adversities as assessed by parental self-report. 5) Psychosocial stress as measured using the Perceived Stress Scale (PSS), and the PSS-short version. 6) Cortisol levels in hair. 7) Microbiological typing of bacterial GAS population. 8) Anti-Streptococcal Immune Response.;Timepoint(s) of evaluation of this end point: 12 months