Erythropoietin Therapy for Children With Cerebral Palsy: Phase 1

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MinYoung Kim, M.D.
• Collaborator: LG Life Sciences
• Treatments: Epoetin Alfa

Criteria

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