Erythropoietin Therapy for Children With Cerebral Palsy

Bundang CHA Hospital

Status and phase: Completed; Phase 2

Conditions: Cerebral Palsy

Treatments: Drug: Erythropoietin; Drug: Placebo erythropoietin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01650415

CPEPO

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 4 months to 4 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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11 participants in 2 patient groups, including a placebo group

Erythropoietin and Rehabilitation

Experimental group

Description:

recombinant human erythropoietin injection and active rehabilitation

Treatment:

Drug: Erythropoietin

Placebo and Rehabilitation

Placebo Comparator group

Description:

Placebo erythropoietin and rehabilitation

Treatment:

Drug: Placebo erythropoietin