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 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT01405950
Eligibility Criteria:
Inclusion Criteria:
* Have clinically diagnosed spasticity resulting from cerebral palsy
* Have a motor disability resulting from a static, nonprogressive brain injury or malformation occurring prenatally or before the age of 2 years
* Have mild to moderate spasticity at screening
* Have a parent or legally accepted representative able to understand and comply with study requirements who voluntarily provides informed consent and agrees to be primarily responsible for adhering to the requirements of the study
Exclusion Criteria:
* Have a history of hypersensitivity or allergic reaction to tizanidine or any of the capsule components
* Have dietary restrictions or food allergies that conflict with a standardized meal
* Have clinically significant psychiatric, gastrointestinal, pulmonary, hematologic, endocrine, cardiovascular, renal, or hepatic disease that requires pharmacologic intervention
* Have an ongoing seizure disorder that requires medical therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
16 Years
Study:
NCT01405950
Study Brief:
Protocol Section:
NCT01405950