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.
BACKGROUND
Tourette Syndrome (TS) is a neurological condition presenting chronic motor and phonic tics, and important degree of comorbidity. Considered an uncommon illness, it first becomes apparent during childhood. Current standard treatment only achieves partial control of the condition, and provokes frequent, and sometimes severe, side effects.


METHODS
Main aim: To show that, 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 TS among children aged 7-14 years, as measured on the Yale Global Tic Severity Scale (YGTSS). Secondary aims: Assess the safety of the treatment. Describe metabolic changes revealed by PET. Measure the impact of the experimental treatment on family life.


METHODS
Randomized, blinded clinical trials. Phase IV study (new proposal for treatment with magnesium and vitamin B6).


METHODS
children in the geographic area of the study group. Recruitment of subjects: to include patients diagnosed with TS, in accordance with DSM-IV criteria (307.23), during a period of exacerbation, and provided none of the exclusion criteria are met.


METHODS
clinical data and the YGTSS score will be obtained at the outset of a period of exacerbation (t0). The examinations will be made after 15 (t1), 30 (t2), 60 (t3) and 90 days (t4). PET will be performed at the t0 and t4. We evaluated decrease in the overall score (t0, t1, t2, t3, t4), PET variations, and impact made by the treatment on the patient's life (Psychological General Well-Being Index).


CONCLUSIONS
Few clinical trials have been carried out on children with TS, but they are necessary, as current treatment possibilities are insufficient and often provoke side effects. The difficulty of dealing with an uncommon illness makes designing such a study all the more complicated. The present study seeks to overcome possible methodological problems by implementing a prior, phase II study, in order to calculate the relevant statistical parameters and to determine the safety of the proposed treatment. Providing a collateral treatment with magnesium and vitamin B6 could improve control of the illness and help reduce side effects. This protocol was approved by the Andalusian Government Committee for Clinical Trials (Spain). This study was funded by the Health Department of the Andalusian Regional Government and by the Healthcare Research Fund of the Carlos III Healthcare Institute (Spanish Ministry of Health).


BACKGROUND
Current Controlled Trials ISRCTN41082378.
Garcia-Lopez
Rafael
R
Department of Anaesthesia and Reanimation, Hospital Costa del Sol, Ctra Nacional 340, km 187, 29603 Marbella, Spain. drgarcia.anest@telefonica.net
Perea-Milla
Emilio
E
Garcia
Cesar Ruiz
CR
Rivas-Ruiz
Francisco
F
Romero-Gonzalez
Julio
J
Moreno
Jose L
JL
Faus
Vicente
V
Aguas
Guadalupe del Castillo
Gdel C
Diaz
Juan C Ramos
JC
D000293:Adolescent; D001479:Basal Ganglia / Q000000981:diagnostic imaging / Q000187:drug effects; D002648:Child; D019587:Dietary Supplements; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005195:Family Relations; D006801:Humans; D049268:Positron-Emission Tomography; D017397:Prefrontal Cortex / Q000000981:diagnostic imaging / Q000187:drug effects; D011761:Pyrrolidonecarboxylic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index; D005879:Tourette Syndrome / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000523:psychology; D016896:Treatment Outcome; D025101:Vitamin B 6 / Q000009:adverse effects / Q000627:therapeutic use*
D025101:Vitamin B 6; D011761:Pyrrolidonecarboxylic Acid