Erythropoietin Therapy for Children With Cerebral Palsy: Phase 1
|ClinicalTrials.gov Identifier: NCT01586052|
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : April 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Drug: Erythropoietin||Phase 1|
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, and anti-inflammation.
On the basis of many experimental studies, erythropoietin is suggested as a potential therapy for cerebral palsy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Clinical Research of Erythropoietin Therapy for Children With Cerebral Palsy: Safety and Efficacy|
|Study Start Date :||June 2012|
|Primary Completion Date :||October 2013|
|Study Completion Date :||October 2013|
Experimental: Erythropoietin and Rehabilitation
recombinant human erythropoietin injection and active rehabilitation
250 IU/kg, Twice a week for 4 weeks
Other Name: Espogen produced by LG Life Science
- Adverse Events [ Time Frame: 8 weeks ]Monitoring of all adverse events during 8 weeks, the study period We selected specially considered adverse events: encephalopathy, intracranial hemorrhage, seizure, hypertension, thromboembolic event, hypoxia, and acute kidney injury. Other adverse events will be recorded. The list was determined by the clinical experience and all adverse reactions reported by the pharmaceutical company.
- Changes in Quality of Movement [ Time Frame: Baseline - 8 weeks ]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).
- Changes in Gross Motor Function [ Time Frame: Baseline - 8 weeks ]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 [ Time Frame: Baseline - 8 weeks ]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 [ Time Frame: Baseline - 8 weeks ]AIMS (Alberta Infant Motor Scale) to assess motor development
- Changes in Spasticity [ Time Frame: Baseline - 8 weeks ]MAS (modified Ashworth Scale) measured at biceps, hip adductor, hamstring, heel cord
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586052
|Korea, Republic of|
|CHA Bundang Medical Center, CHA University|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712|
|Principal Investigator:||Minyoung Kim, M.D., Ph.D.||CHA University|