Back to resultsErythropoietin Therapy for Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Erythropoietin
Placebo erythropoietin
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Erythropoietin, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Cerebral Palsy
- Abnormal Muscle Tone
- Abnormal Brain MRI
- Willing to Comply with All Study Procedure
Exclusion Criteria:
- 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
Sites / Locations
- CHA Bundang Medical Center, CHA University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Erythropoietin and Rehabilitation
Placebo and Rehabilitation
Arm Description
recombinant human erythropoietin injection and active rehabilitation
Placebo erythropoietin and rehabilitation
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
Changes in Motor Development
AIMS (Alberta Infant Motor Scale)to measure the motor development
Changes in Spasticity
MAS (modified Ashworth Scale)measured at biceps, hip adductor, hamstring, heel cord
Full Information
NCT ID
NCT01650415
First Posted
July 24, 2012
Last Updated
October 10, 2017
Sponsor
Bundang CHA Hospital
Collaborators
LG Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01650415
Brief Title
Erythropoietin Therapy for Children With Cerebral Palsy
Official Title
Random Control Trial to Evaluate the Safety and Efficacy of Erythropoietin Therapy for Children With Cerebral Palsy -Patient, Principle Investigator, Observer Blind
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bundang CHA Hospital
Collaborators
LG Life Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Erythropoietin, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erythropoietin and Rehabilitation
Arm Type
Experimental
Arm Description
recombinant human erythropoietin injection and active rehabilitation
Arm Title
Placebo and Rehabilitation
Arm Type
Placebo Comparator
Arm Description
Placebo erythropoietin and rehabilitation
Intervention Type
Drug
Intervention Name(s)
Erythropoietin
Other Intervention Name(s)
Espogen
Intervention Description
twice a week for 1 month
Intervention Type
Drug
Intervention Name(s)
Placebo erythropoietin
Intervention Description
twice a week for 1 month
Primary Outcome Measure Information:
Title
Changes in Quality of Movement
Description
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).
Time Frame
Baseline - 2 months
Secondary Outcome Measure Information:
Title
Changes in Gross Motor Function
Description
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).
Time Frame
Baseline - 2 months
Title
Changes in Neurodevelopmental Outcomes
Description
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).
Time Frame
Baseline - 2 months
Title
Changes in Motor Development
Description
AIMS (Alberta Infant Motor Scale)to measure the motor development
Time Frame
Baseline - 2 months
Title
Changes in Spasticity
Description
MAS (modified Ashworth Scale)measured at biceps, hip adductor, hamstring, heel cord
Time Frame
Baseline - 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cerebral Palsy
Abnormal Muscle Tone
Abnormal Brain MRI
Willing to Comply with All Study Procedure
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minyoung Kim, M.D., Ph.D.
Organizational Affiliation
CHA University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHA Bundang Medical Center, CHA University
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-712
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Erythropoietin Therapy for Children With Cerebral Palsy
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