New therapeutic approach to Tourette Syndrome in children based on a study of the effectiveness and safety of magnesium and vitamin B6
| ISRCTN | ISRCTN41082378 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41082378 |
| EudraCT/CTIS number | 2006-005779-16 |
| Secondary identifying numbers | PI06/90242; 0382/2006; STIII2006 |
- Submission date
- 04/09/2008
- Registration date
- 30/09/2008
- Last edited
- 20/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rafael Garcia-Lopez
Scientific
Scientific
Department of Anaesthesia and Reanimation
Hospital Costa del Sol
Ctra Nacional 340, km 187
Marbella
29603
Spain
| drgarcia.anest@telefonica.net |
Study information
| Study design | Blinded, randomised clinical trial study, phase IV |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | New therapeutic approach to Tourette Syndrome in children based on a randomised placebo-controlled double-blind phase IV study of the effectiveness and safety of magnesium and vitamin B6 |
| Study objectives | With respect to placebo treatment, the combination of 0.5 mEq/Kg magnesium and 2 mg/Kg vitamin B6 reduces motor and phonic tics and incapacity in cases of exacerbated Tourette Syndrome (TS) among children aged 7 - 14 years, as measured on the Yale Global Tic Severity Scale (YGTSS). |
| Ethics approval(s) | Ethics approval received from the Andalusian Government Committee for Clinical Trials on the 11th December 2006. |
| Health condition(s) or problem(s) studied | Tourette Syndrome |
| Intervention | Patients will be randomsied to the following medication: 1. Magnesium pidolate 0.5 mEq/Kg/day, divided to be taken twice daily. This should not be taken in conjunction with calcium or dairy products. 2. Pyroxidine alpha-aketoglutarate 2 mg/Kg/day, once daily The clinical data and the YGTSS score at the onset of the period of exacerbation of the clinical condition (t0) will be noted. The parents/guardians will be informed, and on receipt of their informed consent, the aforementioned medication will be provided. This medication is to be taken orally, at the patient's home, and follow-up will be performed, at the healthcare clinic, at 15 (t1), 30 (t2), 60 (t3) and 90 (t4) days. A positron emission tomography (PET) scan will be performed at the start and end of the experimental period, for 15 patients (applied to the first 15 children in the study in both groups, experimental and control, in t0 and t4). The psychological impact of the treatment on the families concerned will be measured using the Psychological General Well-Being Index (PGWBI). |
| Intervention type | Supplement |
| Primary outcome measure | The clinical diagnosis of TS will be confirmed, and the YGTSS score ascertained, so that the patient may be included in the study and any subsequent fall in the global score recorded (at t0 ,t1, t2, t3 and t4). |
| Secondary outcome measures | Metabolic changes in baseline and post-treatment PET will be recorded. |
| Overall study start date | 01/10/2007 |
| Completion date | 30/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 38 |
| Key inclusion criteria | 1. Aged 7 - 14 years, either sex. This is the age bracket during which the natural course of the illness is most exacerbated. Before the age of 7 years, the tics may not yet have appeared (this generally occurs at the age of 5 - 7 years). After 14 years, symptoms tend to stabilise. 2. Informed consent of the child's parents or guardians, and reasoned agreement with the child 3. Clinical diagnosis of TS, according to Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria 4. Score of 40 or more on the YGTSS |
| Key exclusion criteria | 1. Severe attention deficit hyperactivity disorder (ADHD) or obsessive compulsive disorder (OCD), not clinically controlled 2. Autism 3. Unrelated depression 4. Allergy to acetylsalicylic acid (due to the excipients used) |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 30/05/2009 |
Locations
Countries of recruitment
- Spain
Study participating centre
Department of Anaesthesia and Reanimation
Marbella
29603
Spain
29603
Spain
Sponsor information
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Research organisation
Research organisation
C/ Sinesio Delgado, 6
Madrid
28029
Spain
| Phone | +34 (0)91 822 25 37 |
|---|---|
| Oficina.informacion@isciii.es | |
| Website | http://www.isciii.es/htdocs/en/index.jsp |
"ROR" |
https://ror.org/00ca2c886 |
Funders
Funder type
Government
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) - Healthcare Research Fund (project no. PI06/90242)
No information available
Andalusian Regional Goverment (Spain) - Health Department (project no. 0382/2006)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | analysis of the adapted YGTSS questionnaire | 01/03/2008 | Yes | No | |
| Protocol article | protocol | 10/03/2009 | Yes | No |
