Erythropoietin Therapy for Children With Cerebral Palsy: Phase 1

NCT01586052 | Completed Phase 1

• 1 other identifier: CPEPOPhase1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This purpose of this phase 1 study is to investigate the safety and efficacy of erythropoetin for children with cerebral palsy.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Erythropoietin; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  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.

  8 weeks

Secondary Outcomes (5)

• Changes in Quality of Movement

  Baseline - 8 weeks

• Changes in Gross Motor Function

  Baseline - 8 weeks

• Changes in Neurodevelopmental Outcomes

  Baseline - 8 weeks

• Changes in Motor Development

  Baseline - 8 weeks

• Changes in Spasticity

  Baseline - 8 weeks

Study Arms (1)

Erythropoietin and Rehabilitation

EXPERIMENTAL

recombinant human erythropoietin injection and active rehabilitation

Drug: Erythropoietin

Interventions

Erythropoietin DRUG

250 IU/kg, Twice a week for 4 weeks

Also known as: Espogen produced by LG Life Science

Erythropoietin and Rehabilitation

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MinYoung Kim, M.D.: lead
• LG Life Sciences: collaborator

Study Sites (1)

CHA Bundang Medical Center, CHA University

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

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Minyoung Kim, M.D., Ph.D.

  CHA University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 26, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

KR (1)