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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24924

Enrollment

Registered

2005-12-08

Start date

2004-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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-ef

Eligibility

Inclusion criteria

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

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 outcomes

Secondary

Measure	Time frame
Visual Analogue Scale, World Health Organization Quality Of Life, abbreviated version.	—

Primary

Measure	Time frame
Abnormal Involuntary Movement Scale (AIMS) and the number of patients that wanted to continue the treatment with botulinum toxin after cessation of the study.	—

Contacts

Public ContactC.W. Slotema

Stadhoudersplantsoen 2

c.slotema@parnassia.nl+31 (0)70 3918600

Outcome results