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Completed

NCT Number: NCT01650415

Erythropoietin Therapy for Children With Cerebral Palsy

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 463-712, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythropoietin

Drug

twice a week for 1 month

Other names: Espogen

Placebo erythropoietin

Drug

twice a week for 1 month

Primary outcomes

  1. Changes in Quality of Movement

    Time frame: 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 outcomes

  1. Changes in Gross Motor Function

    Time frame: 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).

  2. Changes in Neurodevelopmental Outcomes

    Time frame: 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).

  3. Changes in Motor Development

    Time frame: Baseline - 2 months

    AIMS (Alberta Infant Motor Scale)to measure the motor development

  4. Changes in Spasticity

    Time frame: Baseline - 2 months

    MAS (modified Ashworth Scale)measured at biceps, hip adductor, hamstring, heel cord

Sponsors and collaborators

Lead sponsor

Bundang CHA Hospital

Other

Collaborators

  • LG Life Sciences

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 26, 2012
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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