search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


European multicenter tics in children studies


- candidate number19545
- NTR NumberNTR4814
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-sep-2014
- Secondary IDs278367 European Commission
- Public TitleEuropean multicenter tics in children studies
- Scientific TitleEuropean multicenter tics in children studies
- ACRONYMEMTICS
- hypothesisPresence of Group A streptococci in children's throat is associated with worsening or onset of tics
- Healt Condition(s) or Problem(s) studiedTics, Tourette syndrome
- Inclusion criteriaONSET:
• First degree relative of person with TS or another chronic tic disorder according to DSM IV-TR criteria (American Psychiatric Association). This may include children with a half-sister/-brother with a tic disorder.
• Aged 3-10 years, male or female
Parents and patients have provided written informed consent and assent as appropriate according to ethical regulation

COURSE:
• TS or another chronic tic disorder according to DSM IV-TR criteria (American Psychiatric Association)
• Age 3 through 16 years, male or female
• Parents and patients have provided written informed consent and assent
- Exclusion criteriaONSET:
• Presence of tics. This will be checked by using the tic check list of the YGTSS.
• Current or previous presence of OCD
• Current or previous presence of trichotillomania
• Serious medical illness
• Child treated with antibiotics in the past 1 month.
• Children and/or parents are unable to understand and comply with protocol.

COURSE:
• Serious medical illness
• Child treated with antibiotics in the past 1 month
• Children and/or parents are unable to understand and comply with protocol
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-dec-2011
- planned closingdate1-jun-2017
- Target number of participants1002
- InterventionsNone
- Primary outcomeThe main study outcome is onset of tics (ONSET study) and tic exacerbation (COURSE study), as assessed by the Yale Global tic severity scale (YGTSS) plus Premonitory Urge for Tics Scale (PUTS).
- Secondary outcomeSecondary parameters are the presence of obsessive-compulsive symptoms as assessed by the Children’s Yale Brown Obsessive-Compulsive Scale (CY-BOCS) and the presence of GAS in throat swabs.
- TimepointsAssessments every four years during 16 months (COURSE) and 3 years (ONSET)
- Trial web sitewww.emtics.eu
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES P.J. Hoekstra
- CONTACT for SCIENTIFIC QUERIES P.J. Hoekstra
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
European Union
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD25-sep-2014 - 25-okt-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl