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: 14.1Level: LLTClassification code 10043834Term: Tic disorder, unspecifiedSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]
- Registration Number
- EUCTR2012-002430-36-ES
- 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
1 Participant and/or parents willing and able to give informed consent for participation in the study 2 Male or Female, aged 3-16. 3 Diagnosis of Tourette Syndrome or another chronic tic disorder according to DSM IV-TR criteria. 4 Evidence of GAS colonization at any visit of EMTICS Longitudinal Course Study. 5 Either no current psychotropic medication or on stable anti-tic medication for at least 2 months before the enrolment in the trial.6 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: 1 Children and/or parents are unable to understand and comply with protocol 2 Any antibiotic treatment for any reason during the last month before enrolment in the trial. 3 Clinical manifestations of pharyngitis or other streptococcal infections at moment of enrolment in the trial. 4 Known or suspected hypersensitivity to penicillin or other -lactam antibacterials, a history of amoxicillin-clavulanate-associated cholestatic jaundice or hepatic dysfunction. 5 Known and/or suspected renal or hepatic impairment (due to the potential for drug-related toxicity in patients with such a condition). 6 Scheduled elective surgery or other procedures requiring general anaesthesia during the study. 7 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 ability to participate in the study. 8 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
- Secondary Outcome Measures
Name Time Method