Cerebral PalsyPhase 2NCT00221611
Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity
A Phase 2 study testing Administration of intrathecal baclofen in people with Cerebral Palsy, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Administration of intrathecal baclofen
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2000to Aug 2006
- Phase
- Phase 2
- 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 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Contra-indications for surgery (e.g. infection)
- Hypersensitivity to oral Baclofen
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales
Read the detailed description
Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales
- Conditions
- Cerebral Palsy
- Being tested
- Administration of intrathecal baclofen
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of intrathecal baclofenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity of patients after 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2000
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Uyttendale, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221611
- Sponsor's protocol ID
- 1999/152
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity
- ClinicalTrials.gov ID
- NCT00221611
- Acronym / sponsor ID
- 1999/152
- Conditions
- Cerebral Palsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2000
- Study completion
- Aug 2006 (actual)
- First posted
- 22 Sep 2005 (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.
Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales
Detailed description
Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Contra-indications for surgery (e.g. infection)
- Hypersensitivity to oral Baclofen
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 |
|---|---|---|
| Administration of intrathecal baclofen | Drug | – |
Primary outcome
Spasticity of patients after 4 years
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 28 Dec 2007.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Dr. Uyttendale, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Administration of intrathecal baclofen in people with Cerebral Palsy, run by University Hospital, Ghent at 1 site in Belgium.
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 5 inclusion and 2 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 28 Dec 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 Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Spasticity of patients after 4 years. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2007.