Cerebral PalsyNCT03303573
Safety and Efficacy of Multiple EPO Injections in Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Bundang CHA Hospital.
Trial summary
This study is a retrospective review on the safety and efficacy of repetitive erythropoietin injection in children with cerebral palsy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- recombinant human erythropoietin
- Type of treatment
- Injection or infusion
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to Aug 2017
- Phase
- Observational
- 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 Any age
- Child, Adult, Older adult
Study population: Children diagnosed with cerebral palsy who had received recombinant human erythropoietin more than once.
Who may be able to join
- confirmed clinical diagnosis of cerebral palsy based on neuromotor findings,
- less than 18 years of age,
- received recombinant human erythropoietin (rhEPO) more than once.
Who cannot join
- not responding to phone interview or
- no functional assessments available.
About this study
Official title: Safety and Efficacy of Repetitive Erythropoietin Treatment for Cerebral Palsy
This study is a retrospective review on the safety and efficacy of repetitive erythropoietin injection in children with cerebral palsy
Read the detailed description
Cerebral palsy is mostly caused by hypoxic-ischemic encephalopathy from preterm birth, involving inflammatory and apoptotic cellular response. Erythropoietin (EPO) has shown neuroprotective effects via activation of anti-inflammatory, angiogenic, and anti-apoptotic pathways. The safety and feasibility of EPO in children were proven in previous clinical trials. In addition, the efficacy of EPO is actively being investigated and some reports have shown potential benefits in cerebral palsy. To confirm the safety and efficacy of multiple injections with expected effect, retrospective review on medical records was performed.
- Conditions
- Cerebral Palsy
- Being tested
- recombinant human erythropoietin
- Keywords
- Erythropoeitin
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human erythropoietinDrug
Also called rhEPO
Subcutaneous rhEPO injection
| Study group | Role | What they receive |
|---|---|---|
| recombinant human erythropoietin group | cerebral palsy patients who had received erythropoietin from January 2013 to November 2016 Receives: Drug: recombinant human erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
telephone interview was conducted to collect information of adverse events from all patients.
Measured: interview was performed at an average of 1 year after the completion of rhEPO injections
Secondary outcomes (1)
Change of Gross Motor Function Measure
The change of GMFM score before and after rhEPO injections
Measured: The results between the baseline evaluation before rhEPO injection and the last evaluation at an average of 1 year after rhEPO injections were compared
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start1 Jan 2013
- Primary completion30 Nov 2016
- Study completionAug 2017
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MinYoung Kim, M.D., Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303573
- Sponsor's protocol ID
- Multiple EPO
- Status last verified
- Oct 2017
- First submitted
- 18 Aug 2017
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Repetitive Erythropoietin Treatment for Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03303573
- Acronym / sponsor ID
- Multiple EPO
- Conditions
- Cerebral Palsy
- Keywords
- Erythropoeitin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 6 Oct 2017 (actual)
- 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.
This study is a retrospective review on the safety and efficacy of repetitive erythropoietin injection in children with cerebral palsy
Detailed description
Cerebral palsy is mostly caused by hypoxic-ischemic encephalopathy from preterm birth, involving inflammatory and apoptotic cellular response. Erythropoietin (EPO) has shown neuroprotective effects via activation of anti-inflammatory, angiogenic, and anti-apoptotic pathways. The safety and feasibility of EPO in children were proven in previous clinical trials. In addition, the efficacy of EPO is actively being investigated and some reports have shown potential benefits in cerebral palsy. To confirm the safety and efficacy of multiple injections with expected effect, retrospective review on medical records was performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| recombinant human erythropoietin group | – | Drug: recombinant human erythropoietincerebral palsy patients who had received erythropoietin from January 2013 to November 2016 |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Children diagnosed with cerebral palsy who had received recombinant human erythropoietin more than once.
Key inclusion criteria (3 listed)
- confirmed clinical diagnosis of cerebral palsy based on neuromotor findings,
- less than 18 years of age,
- received recombinant human erythropoietin (rhEPO) more than once.
Key exclusion criteria (2 listed)
- not responding to phone interview or
- no functional assessments available.
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 |
|---|---|---|
| recombinant human erythropoietinAlso: rhEPOSubcutaneous rhEPO injection | Drug | recombinant human erythropoietin group |
Primary outcome
Adverse events
Time frame: interview was performed at an average of 1 year after the completion of rhEPO injections
telephone interview was conducted to collect information of adverse events from all patients.
1 secondary outcome
Change of Gross Motor Function Measure
Time frame: The results between the baseline evaluation before rhEPO injection and the last evaluation at an average of 1 year after rhEPO injections were compared
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 10 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Bundang CHA Hospital.
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 3 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 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Adverse events (time frame: interview was performed at an average of 1 year after the completion of rhEPO injections). 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 10 Oct 2017.