Cerebral PalsyPhase 2NCT00455637
Which is the Best Dose of Dysport in Helping With Hip Pain for Children With Cerebral Palsy?
A Phase 2 study testing Botulinum toxin type A in people with Cerebral Palsy, run by Ipsen at 1 site in United Kingdom.
Trial summary
The purpose of the study is to compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Botulinum toxin type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2007to 17 Mar 2008
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female aged between 4 and 16 years (inclusive).
- Diagnosis of cerebral palsy.
- Presence of clinical bilateral hip pain (of at least 6 months duration) due to cerebral palsy as defined by the child/young person and/or parents.
- Paediatric Pain Profile score of 25 or greater.
Who cannot join
- Prior treatment with Botulinum toxin (any serotype, administered anywhere in the body) within 4 months prior to Screening.
- Planned or anticipated requirement for surgery during the study period.
- History of hypersensitivity to the investigational drug or any of its excipients.
- Likely to require treatment during the study with drugs that are not permitted by the study protocol or that in the opinion of the Investigator may interfere with the evaluation of the efficacy or safety of the study medication.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chailey Heritage Clinical Services
Chailey, BN8 4JN
About this study
Official title: A Phase II, Randomised, Double-blind, Dose-ranging Study in Children and Young People to Determine the Optimal Dose of Botulinum Toxin Type-A (Dysport®) in Managing the Symptoms of Hip Muscle Spasticity Due to Cerebral Palsy
The purpose of the study is to compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people.
- Conditions
- Cerebral Palsy
- Being tested
- Botulinum toxin type A
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ABiological
Also called AbobotulinumtoxinA (Dysport®)
| Study group | Role | What they receive |
|---|---|---|
| Dysport 5 units | Experimental | Not described Receives: Biological: Botulinum toxin type A |
| Dysport 10 units | Experimental | Not described Receives: Biological: Botulinum toxin type A |
| Dysport 15 units | Experimental | Not described Receives: Biological: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people.
Measured: From baseline to the end of study (week 20)
The primary endpoint will be the change in score in the Paediatric Pain Profile.
Measured: From baseline to the week 4 assessment
Secondary outcomes (3)
To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of hip pain as assessed by the change in the score of the Paediatric Pain Profile at all other assessment time points.
Measured: Weeks 12, 16 and 20
To compare the effect of the different doses of Dysport on sleep pattern and quality as assessed using a sleep diary and sleep questionnaire at all assessment time points.
Measured: Weeks 4, 12, 16 and 20
To compare the effect of the different doses of Dysport on oral analgesia intake for hip pain at all assessment time points.
Measured: Weeks 4, 12, 16 and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startMar 2007
- Primary completion17 Mar 2008
- Study completion17 Mar 2008
Why it stopped: Low levels of recruitment
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 IpsenThe 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
- Double blind
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455637
- Sponsor's protocol ID
- Y-97-52120-727
- Other IDs
- 2005-001794-10, 2005
- Status last verified
- Aug 2019
- First submitted
- 3 Apr 2007
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomised, Double-blind, Dose-ranging Study in Children and Young People to Determine the Optimal Dose of Botulinum Toxin Type-A (Dysport®) in Managing the Symptoms of Hip Muscle Spasticity Due to Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00455637
- Acronym / sponsor ID
- Y-97-52120-727
- Conditions
- Cerebral Palsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low levels of recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- 17 Mar 2008 (actual)
- Study completion
- 17 Mar 2008 (actual)
- First posted
- 4 Apr 2007 (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 purpose of the study is to compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dysport 5 units | Experimental | Biological: Botulinum toxin type A |
| Dysport 10 units | Experimental | Biological: Botulinum toxin type A |
| Dysport 15 units | Experimental | Biological: Botulinum toxin type A |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female aged between 4 and 16 years (inclusive).
- Diagnosis of cerebral palsy.
- Presence of clinical bilateral hip pain (of at least 6 months duration) due to cerebral palsy as defined by the child/young person and/or parents.
- Paediatric Pain Profile score of 25 or greater.
Key exclusion criteria (4 listed)
- Prior treatment with Botulinum toxin (any serotype, administered anywhere in the body) within 4 months prior to Screening.
- Planned or anticipated requirement for surgery during the study period.
- History of hypersensitivity to the investigational drug or any of its excipients.
- Likely to require treatment during the study with drugs that are not permitted by the study protocol or that in the opinion of the Investigator may interfere with the evaluation of the efficacy or safety of the study medication.
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 |
|---|---|---|
| Botulinum toxin type AAlso: AbobotulinumtoxinA (Dysport®) | Biological | Dysport 10 units, Dysport 15 units, Dysport 5 units |
Primary outcome
To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people.
Time frame: From baseline to the end of study (week 20)
The primary endpoint will be the change in score in the Paediatric Pain Profile.
Time frame: From baseline to the week 4 assessment
3 secondary outcomes
To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of hip pain as assessed by the change in the score of the Paediatric Pain Profile at all other assessment time points.
Time frame: Weeks 12, 16 and 20
To compare the effect of the different doses of Dysport on sleep pattern and quality as assessed using a sleep diary and sleep questionnaire at all assessment time points.
Time frame: Weeks 4, 12, 16 and 20
To compare the effect of the different doses of Dysport on oral analgesia intake for hip pain at all assessment time points.
Time frame: Weeks 4, 12, 16 and 20
Results and safety
The study was stopped early (reason given: Low levels of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
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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.
Ipsen Medical Director study director
Ipsen
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 Botulinum toxin type A in people with Cerebral Palsy, run by Ipsen at 1 site in United Kingdom.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 2 Aug 2019. 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 United Kingdom. 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 was stopped early (reason given: Low levels of recruitment). Results are not available in the source record.
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?
To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people. (time frame: From baseline to the end of study (week 20)). The study lists 2 primary outcomes in all. 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 2 Aug 2019.