Erythropoietin Therapy for Children With Cerebral Palsy

NCT ID: NCT01650415

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cerebral Palsy

Keywords

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Cerebral Palsy Erythropoietin Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Erythropoietin and Rehabilitation

recombinant human erythropoietin injection and active rehabilitation

Group Type EXPERIMENTAL

Erythropoietin

Intervention Type DRUG

twice a week for 1 month

Placebo and Rehabilitation

Placebo erythropoietin and rehabilitation

Group Type PLACEBO_COMPARATOR

Placebo erythropoietin

Intervention Type DRUG

twice a week for 1 month

Interventions

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Erythropoietin

twice a week for 1 month

Intervention Type DRUG

Placebo erythropoietin

twice a week for 1 month

Intervention Type DRUG

Other Intervention Names

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Espogen

Eligibility Criteria

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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
Minimum Eligible Age

4 Months

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LG Life Sciences

INDUSTRY

Sponsor Role collaborator

Bundang CHA Hospital

OTHER

Sponsor Role lead

Responsible Party

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MinYoung Kim, M.D.

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Minyoung Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CHA University

Locations

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CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CPEPO

Identifier Type: -

Identifier Source: org_study_id