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

This randomized placebo-controlled trial aims to investigate the efficacy and safety of erythropoetin for children with cerebral palsy.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Drug: Erythropoietin; Drug: Placebo erythropoietin

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
      • CHA Bundang Medical Center, CHA University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erythropoietin and Rehabilitation; recombinant human erythropoietin injection and active rehabilitation	Drug: Erythropoietin; twice a week for 1 month; Other Names: Espogen
Placebo Comparator: Placebo and Rehabilitation; Placebo erythropoietin and rehabilitation	Drug: Placebo erythropoietin; twice a week for 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline - 2 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bundang CHA Hospital
• Collaborators: LG Life Sciences

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimate): July 26, 2012

Study Record Updates

• Last Update Posted (Actual): October 12, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Cerebral Palsy; Erythropoietin
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis; Hematinics; Epoetin Alfa
• Other Study ID Numbers: CPEPO