TerminatedPhase 1

Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy

Stopped: Please see 'Further study details as provided by Acorda Therapeutics' for explanation of why study stopped.

United States10 participantsStarted 2011-05

Plain-language 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.

Who can participate

Age range

2 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT01405950

SponsorAcorda Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-03

Results submitted2013-03-27

View on ClinicalTrials.gov More Spasticity Due to Cerebral Palsy trials