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

NCT01405950 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-06-17

Study results available
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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.

Conditions

  • Spasticity Due to Cerebral Palsy

Interventions

DRUG

Zanaflex Capsules

0.025 mg/kg

DRUG

Zanaflex Capsules

0.05 mg/kg

DRUG

Zanaflex Capsules

0.075 mg/kg

DRUG

Zanaflex Capsules

0.1 mg/kg

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Acorda Therapeutics

    lead INDUSTRY

Principal Investigators

  • Herbert Henney, PharmD · Acorda Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01405950 on ClinicalTrials.gov