Condition category
Nervous System Diseases
Date applied
08/03/2006
Date assigned
08/03/2006
Last edited
19/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr C.W. Slotema

ORCID ID

Contact details

Stadhoudersplantsoen 2
The Hague
2517 JL
Netherlands
+31 (0)70 3918600
c.slotema@parnassia.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR576

Study information

Scientific title

Acronym

Study hypothesis

Botulinum toxin A decreases the severity of tardive dyskinesias.

Ethics approval

Not provided at time of registration

Study design

Single blind uncontrolled study

Primary study design

Interventional

Secondary study design

Other

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Tardive dyskinesia

Intervention

4 injections of 10 mu botulinum toxin A in the orbicularis oris muscle in 3 sessions (1 every 3 months). The dosage could be increased to 15 or 20 mu per injection site, depending on effect and/or side-effects.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Abnormal Involuntary Movement Scale (AIMS)
2. The number of patients that wanted to continue the treatment with botulinum toxin after cessation of the study

Secondary outcome measures

1. Visual Analogue Scale
2. World Health Organization Quality Of Life, abbreviated version

Overall trial start date

01/02/2004

Overall trial end date

31/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients suffering from orofacial tardive dyskinesias for at least 3 months
2. Stable dosage of psychopharmacological medication
3. Written informed consent by the patient

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

14

Participant exclusion criteria

1. Age younger than 18 years
2. Contraindication for botulinum toxin (myasthenia gravis, Lambert Eaton Myasthenic Syndrome)
3. Women known to be pregnant or having a positive pregnancy test

Recruitment start date

01/02/2004

Recruitment end date

31/10/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Stadhoudersplantsoen 2
The Hague
2517 JL
Netherlands

Sponsor information

Organisation

Parnassia Psycho-medical Centre (Netherlands)

Sponsor details

Mangostraat 15
The Hague
2552 KS
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Support Foundation of the Christian Association for the Care of Nervous Disorders (Stichting tot Steun Vereniging tot Christelijke Verzorging van Geestes en Zenuwzieken [VCVGZ]) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ipsen pharmaceutical group (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18022743

Publication citations

  1. Results

    Slotema CW, van Harten PN, Bruggeman R, Hoek HW, Botulinum toxin in the treatment of orofacial tardive dyskinesia: a single blind study., Prog. Neuropsychopharmacol. Biol. Psychiatry, 2008, 32, 2, 507-509, doi: 10.1016/j.pnpbp.2007.10.004.

Additional files

Editorial Notes