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 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
NCT ID:
NCT00287157
Eligibility Criteria:
Inclusion Criteria:
* Males/Females 8-18 years of age with documented history of TBI
* Documented Loss of Consciousness(LOC) for more than 24 H, or initial GCS (Glasgow Coma Score) lower than 8
* Current Spasticity that interferes with task performance
* Patient is able to cooperate and understand general explanations
Exclusion Criteria:
* History of allergy to tizanidine or any inactive component (including lactose intolerance)
* Use of other hypnotic medication within 3 days of baseline visit and during the study
* Botox therapy within 6 weeks of baseline, or use of Baclofen pump during the trial
* Use of CYP1A2 inhibitors (ex. ciprofloxacin or fluvoxamine) for the duration of the study
* Female patients on oral contraceptives
* Significant abnormalities in clinical screening laboratory parameters (ALT, AST, Bilirubin\>2 x uln; Creatinine\>2 mg/dl;WBC \<2300/mm3, platelets\<80,000/mm3)
* Taking of other medications that may adversely interfere with the actions of the study medication or outcome variables within 2 weeks of 5 half-lives of the baseline visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT00287157
Study Brief:
Protocol Section:
NCT00287157