No registrations found.
ID
Source
Brief title
Health condition
N/A
Sponsors and support
Intervention
Outcome measures
Primary outcome
Abnormal Involuntary Movement Scale (AIMS) and the number of patients that wanted to continue the treatment with botulinum toxin after cessation of the study.
Secondary outcome
Visual Analogue Scale, World Health Organization Quality Of Life, abbreviated version.
Background summary
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.
Study objective
Botulinum toxin A declines the severity of tardive dyskinisias.
Study design
N/A
Intervention
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.
C.W. Slotema
Stadhoudersplantsoen 2
Den Haag 2517 JL
The Netherlands
+31 (0)70 3918600
c.slotema@parnassia.nl
C.W. Slotema
Stadhoudersplantsoen 2
Den Haag 2517 JL
The Netherlands
+31 (0)70 3918600
c.slotema@parnassia.nl
Inclusion criteria
Patients suffering from orofacial tardive dyskinisias for at least 3 months, stable dosage of psychopharmacological medication and written informed consent by the patient.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL532 |
| NTR-old | NTR576 |
| Other | : N/A |
| ISRCTN | ISRCTN81508784 |