Status:
TERMINATED
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
Lead Sponsor:
Acorda Therapeutics
Collaborating Sponsors:
Syneos Health
Conditions:
Spasticity Due to Cerebral Palsy
Eligibility:
All Genders
2-16 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
Evaluation of the study's progress after the amendment remained challenging with continued pre-screen failures noted in areas of Botox injection inclusion; family participation refusal / disinterest a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01405950
Start Date
May 1 2011
End Date
March 1 2012
Last Update
June 17 2013
Active Locations (1)
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1
University of Louisville Department of Neurology dba Kentucky Neuroscience Research Health Care Outpatient Center (HCOC)
Louisville, Kentucky, United States, 40202