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Erythropoietin Therapy for Children With Cerebral Palsy: Phase 1

Information source: Bundang CHA Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cerebral Palsy

Intervention: Erythropoietin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: MinYoung Kim, M.D.

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

Summary

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

Clinical Details

Official title: A Phase 1 Clinical Research of Erythropoietin Therapy for Children With Cerebral Palsy: Safety and Efficacy

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Adverse Events

Secondary outcome:

Changes in Quality of Movement

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; neuroprotection effect, angiogenesis, and anti-inflammation. On the basis of many experimental studies, erythropoietin is suggested as a potential therapy for cerebral palsy.

Eligibility

Minimum age: 6 Months. Maximum age: 3 Years. Gender(s): Both.

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

Locations and Contacts

CHA Bundang Medical Center, CHA University, Seongnam-si, Gyeonggi-do 463-712, Korea, Republic of
Additional Information

Starting date: June 2012
Last updated: April 7, 2014

Page last updated: August 20, 2015

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