Cerebral PalsyPhase 3NCT00367068
Dutch National ITB Study in Children With Cerebral Palsy
A Phase 3 study testing baclofen, intrathecal and infusion pump for intrathecal baclofen, Synchromed, Medtronic in people with Cerebral Palsy and Spasticity, run by Maastricht University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Cerebral Palsy, Spasticity
- What is being tested?
- baclofen, intrathecal and infusion pump for intrathecal baclofen, Synchromed, Medtronic
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2002to May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- hypersensitivity to baclofen
- contraindications for general anaesthesia
- insufficient general health
- intractable epileptic seizures
- infection of the lumbar skin
- a systemic infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrathecal Baclofen. Evaluation of a Therapy for Refractory Spasticity in Children With Cerebral Palsy
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.
Read the detailed description
Spasticity in cerebral palsy (CP) is a serious problem leading to pain, sleep disturbance, increased expenditure of energy and/or interference with positioning, transfers, dressing and body hygiene. In later stages, secondary phenomena, such as contractures, decubitus and heterotopic calcifications of joints or tendons may create large treatment problems. A substantial group of children with severe CP does not respond to regular treatments, such as physical therapy, orthopaedic surgery or oral medication. An effective treatment option for intractable spasticity is the continuous delivery of intrathecal baclofen (CITB). In 2000, the American Academy for Cerebral Palsy and Developmental Medicine (AACPDM) published a systematic review on the body of evidence about intrathecal baclofen (ITB) for spasticity in individuals with CP. It appeared that only a small and uncertain number of children had been studied. Except for two case-reports, none of the studies solely concerned children. The research methodology employed in three quarters of the available studies was not capable of confirming treatment effect. The AACPDM underlined the need for further high-level research in the form of prospective, randomized trials that use valid and reliable outcome measures in well described and homogeneous groups.
In 1998 the Dutch Study Group on Child Spasticity designed the Dutch national study on the effectiveness and safety of ITB for refractory spasticity in children with cerebral palsy. The Dutch national ITB study included four phases: 1] the selection phase, 2] the double-blind, placebo-controlled dose-escalation test treatment phase, 3] the prospective, randomized, open-label implantation phase and 4] the follow-up phase.
- Conditions
- Cerebral Palsy, Spasticity
- Being tested
- baclofen, intrathecal, infusion pump for intrathecal baclofen, Synchromed, Medtronic
- Keywords
- Cerebral palsy, Spasticity, Child, Baclofen, Intrathecal injection
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baclofen, intrathecalDrug
infusion pump for intrathecal baclofen, Synchromed, MedtronicDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startJan 2002
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Investigators
- Johan SH Vles, MD, PhD, Prof, Study chair, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367068
- Sponsor's protocol ID
- PF-147
- Status last verified
- Nov 2007
- First submitted
- 21 Aug 2006
- Last updated
- 19 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11034458
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Baclofen. Evaluation of a Therapy for Refractory Spasticity in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00367068
- Acronym / sponsor ID
- PF-147
- Conditions
- Cerebral Palsy, Spasticity
- Keywords
- Cerebral palsy, Spasticity, Child, Baclofen, Intrathecal injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jan 2002
- Study completion
- May 2007 (actual)
- First posted
- 22 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Spasticity in cerebral palsy (CP) is a serious problem leading to pain, sleep disturbance, increased expenditure of energy and/or interference with positioning, transfers, dressing and body hygiene. In later stages, secondary phenomena, such as contractures, decubitus and heterotopic calcifications of joints or tendons may create large treatment problems. A substantial group of children with severe CP does not respond to regular treatments, such as physical therapy, orthopaedic surgery or oral medication. An effective treatment option for intractable spasticity is the continuous delivery of intrathecal baclofen (CITB). In 2000, the American Academy for Cerebral Palsy and Developmental Medicine (AACPDM) published a systematic review on the body of evidence about intrathecal baclofen (ITB) for spasticity in individuals with CP. It appeared that only a small and uncertain number of children had been studied. Except for two case-reports, none of the studies solely concerned children. The research methodology employed in three quarters of the available studies was not capable of confirming treatment effect. The AACPDM underlined the need for further high-level research in the form of prospective, randomized trials that use valid and reliable outcome measures in well described and homogeneous groups.
In 1998 the Dutch Study Group on Child Spasticity designed the Dutch national study on the effectiveness and safety of ITB for refractory spasticity in children with cerebral palsy. The Dutch national ITB study included four phases: 1] the selection phase, 2] the double-blind, placebo-controlled dose-escalation test treatment phase, 3] the prospective, randomized, open-label implantation phase and 4] the follow-up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- hypersensitivity to baclofen
- contraindications for general anaesthesia
- insufficient general health
- intractable epileptic seizures
- infection of the lumbar skin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| baclofen, intrathecal | Drug | – |
| infusion pump for intrathecal baclofen, Synchromed, Medtronic | Device | – |
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2007.
- Background: PubMed 11034458Butler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan SH Vles, MD, PhD, Prof study chair
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing baclofen, intrathecal and infusion pump for intrathecal baclofen, Synchromed, Medtronic in people with Cerebral Palsy and Spasticity, run by Maastricht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For the double-blind, placebo-controlled dose-escalation test treatment phase:. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00367068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2007.