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Botulinum toxin in the treatment of orofacial tardive dyskinesias: a single blind study.


- candidate number1882
- NTR NumberNTR576
- ISRCTNISRCTN81508784
- Date ISRCTN created8-mrt-2006
- date ISRCTN requested7-mrt-2006
- Date Registered NTR8-dec-2005
- Secondary IDsN/A 
- Public TitleBotulinum toxin in the treatment of orofacial tardive dyskinesias: a single blind study.
- Scientific TitleBotulinum toxin A in the treatment of orofacial tardive dyskinesias: a single blind study.
- ACRONYMN/A
- hypothesisBotulinum toxin A declines the severity of tardive dyskinisias.
- Healt Condition(s) or Problem(s) studiedTardive dyskinesia
- Inclusion criteriaPatients suffering from orofacial tardive dyskinisias for at least 3 months, stable dosage of psychopharmacological medication and written informed consent by the patient.
- Exclusion criteriaAge younger than 18 years, contraindication for botulinum toxin (myasthenia gravis, Lambert Eaton Myasthenic Syndrome) and women known to be pregnant or having a positive pregnancy test.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- Type[default]
- Studytypeintervention
- planned startdate 1-feb-2004
- planned closingdate31-okt-2004
- Target number of participants14
- Interventions4 injections of 10mu botulinum toxin A in the orbicularis oris muscle in 3 sessions (1 per 3 months). The dosage could be increased to 15 or 20mu per injection site, depending on effect and/or side-effects.
- Primary outcomeAbnormal Involuntary Movement Scale (AIMS) and the number of patients that wanted to continue the treatment with botulinum toxin after cessation of the study.
- Secondary outcomeVisual Analogue Scale, World Health Organization Quality Of Life, abbreviated version.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES C.W. Slotema
- CONTACT for SCIENTIFIC QUERIES H.W. Hoek
- Sponsor/Initiator Parnassia psychomedisch centrum, circuit wonen
- Funding
(Source(s) of Monetary or Material Support)
Ipsen pharmaceutical group, Stichting tot Steun (VCVGZ)
- PublicationsProg Neuropsychopharmacol Biol Psychiatry. 2008 Feb 15;32(2):507-9. Epub 2007 Oct 13.
- Brief summaryTardive dyskinesias can occur as a severe side-effect after longterm treatment with neuroleptic agents. So far, there is no effective treatment for tardive dyskinesias. A few case studies and one open clinical trial suggested that botulinum toxin may be beneficial in the treatment of orofacial tardive dyskinesias. Therefore, 14 patients with orofacial tardive dyskinesias were included for participation into a study in which the effect of botulinum toxin A was investigated in a single blind session with 3 treatment sessions.
- Main changes (audit trail)
- RECORD8-dec-2005 - 16-jun-2008


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