Cerebral PalsyPhase 3ANTALKINECPNCT02839785
Analgesia and Physiotherapy in Children With Cerebral Palsy (ANTALKINECP)
A Phase 3 study testing Ibuprofen in people with Cerebral Palsy, run by University Hospital, Brest at 3 sites in France.
Trial summary
SPARCLE 1 and 2 studies followed a cohort of 818 children with cerebral palsy (CP) between 8 and 12 (SPARCLE 1) and 13 and 18 years old (SPARCLE 2) interviewed at home. The prevalence of pain in these populations was respectively 60 and 69% while it is about 35% in typically developed children of the same age. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Mar 2017to 19 Sep 2018
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cerebral palsy hemiplegic diplegic or tetraplegic spastic or not.
- Children who feel pain during the pre-screening physiotherapy session with a VAS score above 2.
- Aged 6 to 17 years of both gender.
- Ability to express his/her pain and to measure its intensity with VAS.
- Informed and signed (parents, investigator and child if possible).
Who cannot join
- Lack of physiotherapy.
- Analgesic treatment already available or stopped in the last month.
- Scheduled surgery procedure or botulinum toxin injection during the period of the assessment of pain (around 5 month)
- The last botulinum toxin injection in two months before the inclusion
- Child who feel pain with EVA score superior or equal to 4 at the time of the inclusion outside the sessions of physiotherapy
- Child unable to cooperate.
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- Severe infection or instable vital functions.
- Hypersensitivity to ibuprofen or any of the constituents in the product.
- History of allergy or asthma triggered by taking ibuprofen or substances of near activity such as other NSAIDs and aspirin.
- Allergy to other component of treatment.
- History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.
- Active gastrointestinal ulcer.
- Severe hepatic failure.
- Severe renal failure.
- Uncontrolled severe cardiac failure.
- Systemic Lupus Erythematosus.
- Regular intake of ibuprofen
- Randomisation Criteria:
- Child who feel pain during the physiotherapy session with a mean VAS score above 3 during the screening phase.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Morvan - CHRU Brest
Brest, 29609
Hopitaux de Saint-Maurice
Saint-Maurice, 94410
Ch Lannion-Trestel
Trévou-Tréguignec, 22660
About this study
Official title: Analgesia and Physiotherapy in Children With Cerebral Palsy (ANTALKINECP): Double Blind Cross-over Placebo Controlled Study of Ibuprofen in Children With Cerebral Palsy Undergoing Physiotherapy
SPARCLE 1 and 2 studies followed a cohort of 818 children with cerebral palsy (CP) between 8 and 12 (SPARCLE 1) and 13 and 18 years old (SPARCLE 2) interviewed at home. The prevalence of pain in these populations was respectively 60 and 69% while it is about 35% in typically developed children of the same age.
The main location of the pain for 60% of children with CP was the lower limbs, caused by musculoskeletal pain and movement (for those who can) and therapeutic procedures. In SPARCLE 2, 50% of the children complained about pain during physical therapy.
Read more
If the pain is part of the management of physiotherapy, a recent review showed that for a condition such as chronic back pain, the level of evidence of the effectiveness of physiotherapy techniques in reducing pain is low. The effectiveness of these techniques would include higher efficacy on anxiety than pain itself.
Despite significant involvement of physiotherapists in the management of pain, the focus on pain should increase, in particular taking into account the procedural/induced pain (caused by treatment).
In addition to drugs, physical methods (analgesic therapy) or psychotherapy are used to reduce the pain of children during medical procedures. For the latter most of them require the presence of two individuals to provide the therapy. This is unsuited for out-patient care provided to the majority of children with CP.
Non steroid anti-inflammatory drug (NSAIDs), are first recommended, alone or in combination with the treatment of several indications in child pain (migraine, postoperative pain, etc.). Ibuprofen is commonly used in children during painful procedures and represented the 4th molecule among prescribed per os analgesic drugs in 2008 in the United States.
- Conditions
- Cerebral Palsy
- Being tested
- Ibuprofen, Placebo
- Keywords
- Cerebral palsy, Physiotherapy, Children, Ibuprofen, Pain, Anxiety
- Medical subject headings
- Cerebral Palsy, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called AdvilMed
the child will take orally 30 minutes before each session of physiotherapy 10mg/kg of Ibuprofen (not to exceed 400 mg) in liquid form or placebo.
PlaceboDrug
the child will take orally 30 minutes before each session of physiotherapy 10mg/kg of Ibuprofen (not to exceed 400 mg) in liquid form or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | Active ibuprofen Receives: Drug: Ibuprofen |
| Placebo | Placebo comparator | Placebo of ibuprofen Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of at least 20% of the average VAS between the run-in phase and the treatment phase (placebo and ibuprofen)
Measured: 5 months
Secondary outcomes (4)
Pain
The pain reduction assessed by the Child health questionnaire
Measured: 5 months
Anxiety
The anxiety reduction assessed by a VAS scale.
Measured: 5 months
Quality of life
The increase in quality of life assessed by the CP Child.
Measured: 5 months
Incidence of adverse events
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start29 Mar 2017
- Primary completion19 Sep 2018
- Study completion19 Sep 2018
Why it stopped: Low 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 University Hospital, BrestThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain Brochard, Dr, Principal investigator, University hospital of Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839785
- Sponsor's protocol ID
- ANTALKINECP RB15.213
- Acronym
- ANTALKINECP
- Status last verified
- Sep 2018
- First submitted
- 24 Jun 2016
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia and Physiotherapy in Children With Cerebral Palsy (ANTALKINECP): Double Blind Cross-over Placebo Controlled Study of Ibuprofen in Children With Cerebral Palsy Undergoing Physiotherapy
- ClinicalTrials.gov ID
- NCT02839785
- Acronym / sponsor ID
- ANTALKINECP / ANTALKINECP RB15.213
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Physiotherapy, Children, Ibuprofen, Pain, Anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 21 Jul 2016 (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.
SPARCLE 1 and 2 studies followed a cohort of 818 children with cerebral palsy (CP) between 8 and 12 (SPARCLE 1) and 13 and 18 years old (SPARCLE 2) interviewed at home. The prevalence of pain in these populations was respectively 60 and 69% while it is about 35% in typically developed children of the same age.
The main location of the pain for 60% of children with CP was the lower limbs, caused by musculoskeletal pain and movement (for those who can) and therapeutic procedures. In SPARCLE 2, 50% of the children complained about pain during physical therapy.
If the pain is part of the management of physiotherapy, a recent review showed that for a condition such as chronic back pain, the level of evidence of the effectiveness of physiotherapy techniques in reducing pain is low. The effectiveness of these techniques would include higher efficacy on anxiety than pain itself.
Despite significant involvement of physiotherapists in the management of pain, the focus on pain should increase, in particular taking into account the procedural/induced pain (caused by treatment).
In addition to drugs, physical methods (analgesic therapy) or psychotherapy are used to reduce the pain of children during medical procedures. For the latter most of them require the presence of two individuals to provide the therapy. This is unsuited for out-patient care provided to the majority of children with CP.
Non steroid anti-inflammatory drug (NSAIDs), are first recommended, alone or in combination with the treatment of several indications in child pain (migraine, postoperative pain, etc.). Ibuprofen is commonly used in children during painful procedures and represented the 4th molecule among prescribed per os analgesic drugs in 2008 in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: IbuprofenActive ibuprofen |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo of ibuprofen |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Cerebral palsy hemiplegic diplegic or tetraplegic spastic or not.
- Children who feel pain during the pre-screening physiotherapy session with a VAS score above 2.
- Aged 6 to 17 years of both gender.
- Ability to express his/her pain and to measure its intensity with VAS.
- Informed and signed (parents, investigator and child if possible).
Key exclusion criteria (19 listed)
- Lack of physiotherapy.
- Analgesic treatment already available or stopped in the last month.
- Scheduled surgery procedure or botulinum toxin injection during the period of the assessment of pain (around 5 month)
- The last botulinum toxin injection in two months before the inclusion
- Child who feel pain with EVA score superior or equal to 4 at the time of the inclusion outside the sessions of physiotherapy
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 |
|---|---|---|
| IbuprofenAlso: AdvilMedthe child will take orally 30 minutes before each session of physiotherapy 10mg/kg of Ibuprofen (not to exceed 400 mg) in liquid form or placebo. | Drug | Ibuprofen |
| Placebothe child will take orally 30 minutes before each session of physiotherapy 10mg/kg of Ibuprofen (not to exceed 400 mg) in liquid form or placebo. | Drug | Placebo |
Primary outcome
Reduction of at least 20% of the average VAS between the run-in phase and the treatment phase (placebo and ibuprofen)
Time frame: 5 months
4 secondary outcomes
Pain
Time frame: 5 months
Anxiety
Time frame: 5 months
Quality of life
Time frame: 5 months
Incidence of adverse events
Time frame: 5 months
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
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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.
Sylvain Brochard, Dr principal investigator
University hospital of Brest
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibuprofen in people with Cerebral Palsy, run by University Hospital, Brest at 3 sites in France.
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 19 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 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Low 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?
Reduction of at least 20% of the average VAS between the run-in phase and the treatment phase (placebo and ibuprofen) (time frame: 5 months). 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 27 Sep 2018.