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Erythropoietin Therapy for Children With Cerebral Palsy

Information source: Bundang CHA Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cerebral Palsy

Intervention: Erythropoietin (Drug); Placebo erythropoietin (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Bundang CHA Hospital

Official(s) and/or principal investigator(s):
Minyoung Kim, M.D., Ph.D., Principal Investigator, Affiliation: CHA University

Overall contact:
Minyoung Kim, M.D., Ph.D., Phone: 82-31-780-1872, Email: kmin@cha.ac.kr

Summary

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

Clinical Details

Official title: Random Control Trial to Evaluate the Safety and Efficacy of Erythropoietin Therapy for Children With Cerebral Palsy -Patient, Principle Investigator, Observer Blind

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Changes in Quality of Movement

Secondary outcome:

Changes in Gross Motor Function

Changes in Neurodevelopmental Outcomes

Changes in Motor Development

Changes in Spasticity

Detailed 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.

Eligibility

Minimum age: 4 Months. Maximum age: 4 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Minyoung Kim, M.D., Ph.D., Phone: 82-31-780-1872, Email: kmin@cha.ac.kr

CHA Bundang Medical Center, CHA University, Seongnam-si, Gyeonggi-do 463-712, Korea, Republic of; Not yet recruiting
Minyoung Kim, M.D., Ph.D., Phone: 82-31-780-1872, Email: kmin@cha.ac.kr
Kyunghoon Min, M.D., Phone: 82-10-8973-3732, Email: minkh@chamc.co.kr
Kyunghoon Min, M.D., Sub-Investigator
Junyoung Song, M.D., Sub-Investigator
Additional Information

Starting date: September 2014
Last updated: March 31, 2014

Page last updated: August 23, 2015

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