Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Spasticity Due to Cerebral Palsy |
Drug: Zanaflex Capsules |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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. [ Time Frame: Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours ] [ Designated as safety issue: No ]
Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day
0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine
PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp).
- 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. [ Time Frame: Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours ] [ Designated as safety issue: No ]
Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day
0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine
PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp).
| Enrollment: | 10 |
| Study Start Date: | May 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dose Level 1 |
Drug: Zanaflex Capsules
0.025 mg/kg
Other Name: tizanidine HCI (hydrochloride)
|
| Experimental: Dose Level 2 |
Drug: Zanaflex Capsules
0.05 mg/kg
Other Name: tizanidine HCI (hydrochloride)
|
| Experimental: Dose Level 3 |
Drug: Zanaflex Capsules
0.075 mg/kg
Other Name: tizanidine HCI (hydrochloride)
|
| Experimental: Dose Level 4 |
Drug: Zanaflex Capsules
0.1 mg/kg
Other Name: tizanidine HCI (hydrochloride)
|
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| Ages Eligible for Study: | 2 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01405950
| United States, Kentucky | |
| University of Louisville Department of Neurology dba Kentucky Neuroscience Research Health Care Outpatient Center (HCOC) | |
| Louisville, Kentucky, United States, 40202 | |
| Study Director: | Herbert Henney, PharmD | Acorda Therapeutics |
More Information
No publications provided
| Responsible Party: | Acorda Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01405950 History of Changes |
| Other Study ID Numbers: | AT10-ZC-08 |
| Study First Received: | July 25, 2011 |
| Results First Received: | March 27, 2013 |
| Last Updated: | June 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Tizanidine Adrenergic Agents Adrenergic Agonists Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Analgesics Anticonvulsants |
Autonomic Agents Central Nervous System Agents Molecular Mechanisms of Pharmacological Action Muscle Relaxants, Central Neuromuscular Agents Neurotransmitter Agents Parasympatholytics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015