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Completed

NCT Number: NCT01586052

Erythropoietin Therapy for Children With Cerebral Palsy: Phase 1

This purpose of this phase 1 study is to investigate the safety and efficacy 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

6 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

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, and anti-inflammation.

On the basis of many experimental studies, erythropoietin is suggested as a potential therapy 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
  • GMFCS (Gross Motor Functional Classification System): II to IV
  • Age: 6 months ~ 3 years
  • Abnormal Brain MRI compatible to clinical features and non-progressive
  • Willing to Comply with All Study Procedure

Exclusion criteria

  • Known Genetic Disorder
  • Baseline Erythropoietin level > 45 mU/mL
  • Presence of Drug Hypersensitivity Related to the Study Remedy
  • Previous Erythropoietin Treatment before 3 months
  • Coagulopathy:

Family History, Unknown Cerebral Infarction, Thromboembolic Events History

  • Intractable Seizure Disorder
  • Poor Cooperation of Guardian including Inactive Attitude for Rehabilitation
  • Uncontrolled Hypertension
  • Liver Dysfunction
  • Renal Dysfunction
  • Absolute Neutrophil Count < 500/dL
  • Intracerebral or Intraventricular Hemorrhage
  • Malignancy

Treatment and study plan

Erythropoietin

Drug

250 IU/kg, Twice a week for 4 weeks

Other names: Espogen produced by LG Life Science

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. Changes in Motor Development

    Time frame: Baseline - 8 weeks

    AIMS (Alberta Infant Motor Scale) to assess motor development

  5. Changes in Spasticity

    Time frame: Baseline - 8 weeks

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

Sponsors and collaborators

Lead sponsor

MinYoung Kim, M.D.

Other

Collaborators

  • LG Life Sciences

Registry information

Official study title

A Phase 1 Clinical Research of Erythropoietin Therapy for Children With Cerebral Palsy: Safety and Efficacy

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 26, 2012
Registry last updated
Apr 8, 2014

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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