Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT01018056
Eligibility Criteria:
Inclusion Criteria:
* Tourette syndrome (criteria based on the TS Classification Study Group), which includes onset before 18 years, multiple involuntary motor tics, one or more vocal tics, a waxing and waning course, the gradual replacement of old symptoms with new ones, the presence of tics for more than one year, the absence of other medical explanations (effects of a substance (e.g., stimulants) or a general medical condition for tics, and observation of tics by a reliable examiner) or Chronic Motor Tic disorder (criteria similar to Tourette syndrome except for the absence of vocal tics)
* Age 8-17 years, either gender
* Observable tics, achieving a minimum score of \> 22 on the Total Tic score of Yale Global Tic Severity Scale (YGTSS)
* Tic symptoms severe enough to warrant therapy (e.g., causing psycho-social or physical difficulty)
* Written informed consent provided by the patient's parent (or legal guardian) and assent provided by the patient consistent with Institutional Review Board requirements
* Ability and willingness to comply with study protocol requirements
* Women of childbearing potential must be using a medically acceptable contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, injectable contraceptives and estrogen patch, double barrier method (spermicide+diaphragm), or abstinence
* Baseline weight of at least 33 kilograms
* Tic-suppressing drug naive, or currently not on treatment for TS (off medications for at least three weeks), or if, in the judgment of the PI, they are not adequately managed using current therapy (prescribed for greater than one month) and are willing to maintain a constant dose throughout the protocol.
Exclusion Criteria:
* Secondary tics
* Significant medical illness (metabolic, endocrine, cardiac, hematological, gastrointestinal, pulmonary, epilepsy)
* Current major depression
* generalized anxiety disorder
* separation anxiety disorder
* psychotic symptoms (based on clinical evaluation and the results of the CY-BOCS, CDI-S, and MASC evaluations)
* pervasive developmental disorder
* autism
* mental retardation (I.Q. less than 70)
* anorexia/bulimia, or substance abuse
* Any other conditions that in the opinion of the Investigators would interfere with the evaluation of the results or constitute a health hazard for the patient
* Pregnancy
* Hypersensitivity to D-serine or riluzole
* Abnormal laboratory values on screening laboratory testing if clinically significant at the Principal Investigator's discretion.
Subjects with co-morbid ADHD, obsessive compulsive disorder (OCD), and conduct disorder will not be excluded as long as these diagnoses are not the subject's primary problem
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT01018056
Study Brief:
Protocol Section:
NCT01018056