Cerebral PalsyPhase 2NCT01650415
Erythropoietin Therapy for Children With Cerebral Palsy
A Phase 2 study testing Erythropoietin in people with Cerebral Palsy, run by Bundang CHA Hospital at 1 site in South Korea.
Trial summary
This randomized placebo-controlled trial aims to investigate the efficacy and safety of erythropoetin for children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 months to 4 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Erythropoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Dec 2015
- 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 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cerebral Palsy
- Abnormal Muscle Tone
- Abnormal Brain MRI
- Willing to Comply with All Study Procedure
Who cannot join
- Known Genetic Disorder
- Other Etiologies Contributing Developmental Delay
- Coagulopathy
- Initial high Erythropoietin level in Serum
- Previous Erythropoietin Treatment before 3 months
- Presence of Drug Hypersensitivity Related to the Study Remedy
- Intractable Seizure Disorder
- Poor Cooperation of Guardian including Inactive Attitude for Rehabilitation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 463-712
About this study
Official title: Random Control Trial to Evaluate the Safety and Efficacy of Erythropoietin Therapy for Children With Cerebral Palsy -Patient, Principle Investigator, Observer Blind
This randomized placebo-controlled trial aims to investigate the efficacy and safety of erythropoetin for children with cerebral palsy.
Read the detailed description
Cerebral palsy is a disorder of movement and posture resulted from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.
Many experimental animal studies have revealed that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed as follows;
- Neuroprotection effect
- Angiogenesis
- Anti-inflammation.
On the basis of many experimental studies, erythropoietin is suggested as a therapeutic method for cerebral palsy.
- Conditions
- Cerebral Palsy
- Being tested
- Erythropoietin, Placebo erythropoietin
- Keywords
- Cerebral Palsy, Erythropoietin, Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
Also called Espogen
twice a week for 1 month
Placebo erythropoietinDrug
twice a week for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin and Rehabilitation | Experimental | recombinant human erythropoietin injection and active rehabilitation Receives: Drug: Erythropoietin |
| Placebo and Rehabilitation | Placebo comparator | Placebo erythropoietin and rehabilitation Receives: Drug: Placebo erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Quality of Movement
GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones: alignment, coordination, dissociated movement, stability, and weight shift. The interrater reliability of GMPM subscores and total scores was 0.758-0.886 (subject n=75, tester n=10).
Measured: Baseline - 2 months
Secondary outcomes (4)
Changes in Gross Motor Function
GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of 6 sub-scales; lying \& rolling, sitting, crawling \& kneeling, standing, walking, running \& jumping. The measured interrater reliability of GMFM subscores and total scores was 0.974 - 0.997 (subject n=101, tester n=10) and intrarater reliability of GMFM subscores and total scores between one most experienced rater and another newly t rained rater was 0.994 - 1.000 (subject n=101, tester n=2).
Measured: Baseline - 2 months
Changes in Neurodevelopmental Outcomes
K-BSID-II (Korean version of Bayley Scale of Infant Development-II) Motor and Mental Scales. The measured intrarater and interrater reliability of K-BSID-II motor and mental scales was 0.92 - 0.99 (subject n=55, tester n=10).
Measured: Baseline - 2 months
Changes in Motor Development
AIMS (Alberta Infant Motor Scale)to measure the motor development
Measured: Baseline - 2 months
Changes in Spasticity
MAS (modified Ashworth Scale)measured at biceps, hip adductor, hamstring, heel cord
Measured: Baseline - 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionDec 2015
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LG Life Sciences
- Responsible party
- Principal investigator, MinYoung Kim, M.D., Bundang CHA Hospital
- Investigators
- Minyoung Kim, M.D., Ph.D., Principal investigator, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650415
- Sponsor's protocol ID
- CPEPO
- Status last verified
- Oct 2017
- First submitted
- 24 Jul 2012
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Random Control Trial to Evaluate the Safety and Efficacy of Erythropoietin Therapy for Children With Cerebral Palsy -Patient, Principle Investigator, Observer Blind
- ClinicalTrials.gov ID
- NCT01650415
- Acronym / sponsor ID
- CPEPO
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Erythropoietin, Rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Collaborators
- LG Life Sciences
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Jul 2012 (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.
This randomized placebo-controlled trial aims to investigate the efficacy and safety of erythropoetin for children with cerebral palsy.
Detailed description
Cerebral palsy is a disorder of movement and posture resulted from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.
Many experimental animal studies have revealed that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed as follows;
- Neuroprotection effect
- Angiogenesis
- Anti-inflammation.
On the basis of many experimental studies, erythropoietin is suggested as a therapeutic method for cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin and Rehabilitation | Experimental | Drug: Erythropoietinrecombinant human erythropoietin injection and active rehabilitation |
| Placebo and Rehabilitation | Placebo comparator | Drug: Placebo erythropoietinPlacebo erythropoietin and rehabilitation |
Who may qualify
- Ages
- 4 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Cerebral Palsy
- Abnormal Muscle Tone
- Abnormal Brain MRI
- Willing to Comply with All Study Procedure
Key exclusion criteria (8 listed)
- Known Genetic Disorder
- Other Etiologies Contributing Developmental Delay
- Coagulopathy
- Initial high Erythropoietin level in Serum
- Previous Erythropoietin Treatment before 3 months
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 |
|---|---|---|
| ErythropoietinAlso: Espogentwice a week for 1 month | Drug | Erythropoietin and Rehabilitation |
| Placebo erythropoietintwice a week for 1 month | Drug | Placebo and Rehabilitation |
Primary outcome
Changes in Quality of Movement
Time frame: Baseline - 2 months
GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones: alignment, coordination, dissociated movement, stability, and weight shift. The interrater reliability of GMPM subscores and total scores was 0.758-0.886 (subject n=75, tester n=10).
4 secondary outcomes
Changes in Gross Motor Function
Time frame: Baseline - 2 months
Changes in Neurodevelopmental Outcomes
Time frame: Baseline - 2 months
Changes in Motor Development
Time frame: Baseline - 2 months
Changes in Spasticity
Time frame: Baseline - 2 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 12 Oct 2017.
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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.
Minyoung Kim, M.D., Ph.D. principal investigator
CHA University
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 Erythropoietin in people with Cerebral Palsy, run by Bundang CHA Hospital at 1 site in South Korea.
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 8 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 12 Oct 2017. 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 South Korea. 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 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?
Changes in Quality of Movement (time frame: Baseline - 2 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 12 Oct 2017.