Erythropoietin Therapy for Children With Cerebral Palsy

Random Control Trial to Evaluate the Safety and Efficacy of Erythropoietin Therapy for Children With Cerebral Palsy -Patient, Principle Investigator, Observer Blind

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01650415

Enrollment

Registered

2012-07-26

Start date

2014-09-30

Completion date

2015-12-31

Last updated

2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy, Erythropoietin, Rehabilitation

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; 1. Neuroprotection effect 2. Angiogenesis 3. Anti-inflammation. On the basis of many experimental studies, erythropoietin is suggested as a therapeutic method for cerebral palsy.

Interventions

DRUGErythropoietin

twice a week for 1 month

DRUGPlacebo erythropoietin

twice a week for 1 month

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Months to 4 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in Quality of Movement	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).

Secondary

Measure	Time frame	Description
Changes in Gross Motor Function	Baseline - 2 months	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	Baseline - 2 months	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	Baseline - 2 months	AIMS (Alberta Infant Motor Scale)to measure the motor development
Changes in Spasticity	Baseline - 2 months	MAS (modified Ashworth Scale)measured at biceps, hip adductor, hamstring, heel cord

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026