NCT00221611

Brief Summary

Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

September 12, 2005

Last Update Submit

December 19, 2007

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Spasticity of patients after 4 years

Interventions

Administration of intrathecal baclofenDRUG

Eligibility Criteria

Age5 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • CP patients with therapy-resistent spasticity
  • Patients with sufficient body weight in relation to the volume
  • Oral medication has failed: insufficient effect or too many side-effects
  • The patient and family understand the objectives of the treatment and accept those objectives
  • Informed Consent

You may not qualify if:

  • Contra-indications for surgery (e.g. infection)
  • Hypersensitivity to oral Baclofen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Dr. Uyttendale, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

January 1, 2000

Study Completion

August 1, 2006

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

BE(1)