Erythropoietin Therapy for Children With Cerebral Palsy

Phase 2

Completed

• Conditions: Cerebral Palsy
• Interventions: Drug: Placebo erythropoietin; Drug: Erythropoietin

• Registration Number: NCT01650415
• Lead Sponsor: Bundang CHA Hospital

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.

Study Timeline

• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-26
• Study Start: 2014-09
• Primary Completion: 2015-02
• Study Completion: 2015-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo and Rehabilitation	Placebo erythropoietin	Placebo erythropoietin and rehabilitation
Erythropoietin and Rehabilitation	Erythropoietin	recombinant human erythropoietin injection and active rehabilitation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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).

Trial Locations

Locations (1)

CHA Bundang Medical Center, CHA University; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of