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Clinical Trials/ISRCTN41082378
ISRCTN41082378
Completed
Not Applicable

ew 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

The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)0 sites38 target enrollmentSeptember 30, 2008
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Enrollment
38
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 30, 2008
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

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

Eligibility Criteria

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

Exclusion Criteria

  • •1\. Severe attention deficit hyperactivity disorder (ADHD) or obsessive compulsive disorder (OCD), not clinically controlled
  • •3\. Unrelated depression
  • •4\. Allergy to acetylsalicylic acid (due to the excipients used)

Outcomes

Primary Outcomes

Not specified

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