Botulinum toxin A declines the severity of tardive dyskinisias.
ID
Bron
Verkorte titel
Aandoening
N/A
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Abnormal Involuntary Movement Scale (AIMS) and the number of patients that wanted to continue the treatment with botulinum toxin after cessation of the study.
Achtergrond van het onderzoek
Tardive 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.
Doel van het onderzoek
Botulinum toxin A declines the severity of tardive dyskinisias.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
4 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.
Publiek
C.W. Slotema
Stadhoudersplantsoen 2
Den Haag 2517 JL
The Netherlands
+31 (0)70 3918600
c.slotema@parnassia.nl
Wetenschappelijk
C.W. Slotema
Stadhoudersplantsoen 2
Den Haag 2517 JL
The Netherlands
+31 (0)70 3918600
c.slotema@parnassia.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients suffering from orofacial tardive dyskinisias for at least 3 months, stable dosage of psychopharmacological medication and written informed consent by the patient.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Age 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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL532 |
| NTR-old | NTR576 |
| Ander register | : N/A |
| ISRCTN | ISRCTN81508784 |