Botulinum toxin in the treatment of orofacial tardive dyskinesias: a single blind study
| ISRCTN | ISRCTN81508784 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81508784 |
| Protocol serial number | NTR576 |
| Sponsor | Parnassia Psycho-medical Centre (Netherlands) |
| Funders | 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), Ipsen pharmaceutical group (Netherlands) |
- Submission date
- 08/03/2006
- Registration date
- 08/03/2006
- Last edited
- 19/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr C.W. Slotema
Scientific
Scientific
Stadhoudersplantsoen 2
The Hague
2517 JL
Netherlands
| Phone | +31 (0)70 3918600 |
|---|---|
| c.slotema@parnassia.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single blind uncontrolled study |
| Secondary study design | Other |
| Scientific title | |
| Study objectives | Botulinum toxin A decreases the severity of tardive dyskinesias. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Abnormal Involuntary Movement Scale (AIMS) |
| Key secondary outcome measure(s) |
1. Visual Analogue Scale |
| Completion date | 31/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 14 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2004 |
| Date of final enrolment | 31/10/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Stadhoudersplantsoen 2
The Hague
2517 JL
Netherlands
2517 JL
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/02/2008 | Yes | No |
