Clinical trial NCT01405950: Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
Official title: Single-Dose, Phase 1b Study to Assess Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects With Mild to Moderate Spasticity Due to Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Spasticity Due to Cerebral Palsy
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2011-07-29
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral Palsy.

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 and gastric or jejunostomy tube placement. A third protocol amendment to improve enrollment was discussed with the Investigators who did not believe further amendment would overcome the barriers expressed by parents that would subject their children to an intense study time commitment without direct benefit. The investigative sites were notified that the study was closed to enrollment March 27, 2012.

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

Primary outcomes:
measure: Pharmacokinetic (PK) Parameter AUC0-8 (Area Under the Concentration-time Curve From Time 0 to 8 Hours) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.
timeFrame: Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Secondary outcomes:
measure: Pharmacokinetic (PK) Parameter Cmax (Maximum Observed Drug Concentration in Plasma) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.
timeFrame: Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Department of Neurology dba Kentucky Neuroscience Research Health Care Outpatient Center (HCOC)
state: Kentucky
Study officials:
affiliation: Acorda Therapeutics
name: Herbert Henney, PharmD
role: STUDY_DIRECTOR
References: