Dutch National ITB Study in Children With Cerebral Palsy

NCT00367068 | Completed Phase 3

• 1 other identifier: PF-147
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cerebral palsy; Spasticity; Child; Baclofen; Intrathecal injection

Outcome Measures

Primary Outcomes (4)

• For the double-blind, placebo-controlled dose-escalation test treatment phase:

• original Ashworth Scale.

• For the prospective, randomized, open-label implantation and follow-up phase:

• PEDI, GMFM, original Ashworth Scale, Visual Analogue Scale (VAS) at 6 months.

Secondary Outcomes (4)

• For the double-blind, placebo-controlled dose-escalation test treatment phase:

• Visual Analogue Scale (VAS).

• For the prospective, randomized, open-label implantation and follow-up phase:

• CHQ-PF50 at 6 months.

Interventions

baclofen, intrathecal DRUG

infusion pump for intrathecal baclofen, Synchromed, Medtronic DEVICE

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between 4 and 16 years
• spastic diplegia or tetraplegia as part of CP
• insufficient response to oral spasticity-reducing medication
• in a mixed CP syndrome, spasticity has to be the most prominent sign
• spasticity results in a decrease in the quality of life of the child and/or its caregivers
• sufficient motivation for participation in the study including availability for follow-up
• magnetic resonance imaging of the brain rules out progressive causes of spasticity

You may not qualify if:

• hypersensitivity to baclofen
• contraindications for general anaesthesia
• insufficient general health
• intractable epileptic seizures
• infection of the lumbar skin
• a systemic infection

Sponsors & Collaborators

• Maastricht University: lead
• Medtronic: collaborator

Study Sites (1)

University Hospital Maastricht

Maastricht, NL 6202 AZ, Netherlands

Location

Related Publications (1)

• Butler C, Campbell S. Evidence of the effects of intrathecal baclofen for spastic and dystonic cerebral palsy. AACPDM Treatment Outcomes Committee Review Panel. Dev Med Child Neurol. 2000 Sep;42(9):634-45. doi: 10.1017/s0012162200001183. No abstract available.

  PMID: 11034458 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Interventions

Baclofen; Infusion Pumps

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• Johan SH Vles, MD, PhD, Prof

  Maastricht University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 21, 2006
• First Posted: August 22, 2006
• Study Start: January 1, 2002
• Study Completion: May 1, 2007
• Last Updated: November 19, 2007

Record last verified: 2007-11

Locations

NL (1)