Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
Stopped early · Phase 1
Conditions studied: Spasticity Due to Cerebral Palsy
In brief
A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral Palsy.
Key facts
- Study ID
- NCT01405950
- Run by
- Acorda Therapeutics
- People needed
- 10
- Starts
- 2011-05-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2013-06-17
Who can join
Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Louisville Department of Neurology dba Kentucky Neuroscience Research Health Care Outpatient Center (HCOC) — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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