MedTrace Logo

Dutch National ITB Study in Children With Cerebral Palsy

NCT00367068 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2007-11-19

No results posted yet for this study

Summary

The objective of this study is to determine the efficacy and safety of treatment with intrathecal baclofen for severe spasticity in children with cerebral palsy.

Conditions

  • Cerebral Palsy
  • Spasticity

Interventions

DRUG

baclofen, intrathecal

DEVICE

infusion pump for intrathecal baclofen, Synchromed, Medtronic

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Maastricht University

    lead OTHER

Principal Investigators

  • Johan SH Vles, MD, PhD, Prof · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2002-01-31
Completion
2007-05-31

Countries

  • Netherlands

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 NCT00367068 on ClinicalTrials.gov