Condition category
Mental and Behavioural Disorders
Date applied
04/09/2008
Date assigned
30/09/2008
Last edited
20/07/2009
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 Rafael Garcia-Lopez

ORCID ID

Contact details

Department of Anaesthesia and Reanimation
Hospital Costa del Sol
Ctra Nacional 340
km 187
Marbella
29603
Spain
drgarcia.anest@telefonica.net

Additional identifiers

EudraCT number

2006-005779-16

ClinicalTrials.gov number

Protocol/serial number

PI06/90242; 0382/2006; STIII2006

Study information

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

Acronym

Study hypothesis

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

Ethics approval received from the Andalusian Government Committee for Clinical Trials on the 11th December 2006.

Study design

Blinded, randomised clinical trial study, phase IV

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase IV

Drug names

Magnesium, vitamin B6

Primary outcome measures

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 trial start date

01/10/2007

Overall trial end date

30/05/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

38

Participant 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)

Recruitment start date

01/10/2007

Recruitment end date

30/05/2009

Locations

Countries of recruitment

Spain

Trial participating centre

Department of Anaesthesia and Reanimation
Marbella
29603
Spain

Sponsor information

Organisation

The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)

Sponsor details

C/ Sinesio Delgado
6
Madrid
28029
Spain
+34 (0)91 822 25 37
Oficina.informacion@isciii.es

Sponsor type

Research organisation

Website

http://www.isciii.es/htdocs/en/index.jsp

Funders

Funder type

Government

Funder name

The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) - Healthcare Research Fund (project no. PI06/90242)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Andalusian Regional Goverment (Spain) - Health Department (project no. 0382/2006)

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

1. 2008 analysis of the adapted YGTSS questionnaire in http://www.ncbi.nlm.nih.gov/pubmed/18351564
2. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19284553

Publication citations

  1. Analysis of the adapted YGTSS questionnaire

    García-López R, Perea-Milla E, Romero-González J, Rivas-Ruiz F, Ruiz-García C, Oviedo-Joekes E, de Las Mulas-Bejar M, [Spanish adaptation and diagnostic validity of the Yale Global Tics Severity Scale]., Rev Neurol, 46, 5, 261-266.

  2. Protocol

    Garcia-Lopez R, Perea-Milla E, Garcia CR, Rivas-Ruiz F, Romero-Gonzalez J, Moreno JL, Faus V, Aguas Gdel C, Diaz JC, New therapeutic approach to Tourette Syndrome in children based on a randomized placebo-controlled double-blind phase IV study of the effectiveness and safety of magnesium and vitamin B6., Trials, 2009, 10, 16, doi: 10.1186/1745-6215-10-16.

Additional files

Editorial Notes