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Evaluating the Safety and Efficacy of Fixed-dose Once-weekly Oral Aripiprazole in Children and Adolescents with Touretteâ??s Disorder

Phase 3
Conditions
Health Condition 1: null- Children and Adolescents with Touretteâ??s Disorder
Registration Number
CTRI/2012/08/002886
Lead Sponsor
Otsuka Pharmaceutical Development Commercialization Inc
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Other (Terminated)
Sex
Not specified
Target Recruitment
192
Inclusion Criteria

The subject is a male or female child or adolescent, 7 to 17 years of age (inclusive) at the time of signing the informed consent/assent.

Exclusion Criteria

The subject presents with a clinical presentation and/or history that is consistent with another

neurologic condition that may have accompanying abnormal movements.

These include, but are not limited to, the following:

• Transient Tic disorder

• Huntingtons disease

• Parkinsons disease

• Sydenhams chorea

• Wilsons disease

• Mental retardation

• Pervasive developmental disorder

• Traumatic brain injury

• Stroke

• Restless Legs Syndrome

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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