Safety and Efficacy of Multiple EPO Injections in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Safety and Efficacy of Repetitive Erythropoietin Treatment for Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03303573
• Other study ID #: Multiple EPO
• Status: Completed
• Phase: N/A
• First received: August 18, 2017
• Last updated: October 7, 2017
• Start date: January 1, 2013
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: Bundang CHA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a retrospective review on the safety and efficacy of repetitive erythropoietin injection in children with cerebral palsy

Description:

Cerebral palsy is mostly caused by hypoxic-ischemic encephalopathy from preterm birth, involving inflammatory and apoptotic cellular response. Erythropoietin (EPO) has shown neuroprotective effects via activation of anti-inflammatory, angiogenic, and anti-apoptotic pathways. The safety and feasibility of EPO in children were proven in previous clinical trials. In addition, the efficacy of EPO is actively being investigated and some reports have shown potential benefits in cerebral palsy. To confirm the safety and efficacy of multiple injections with expected effect, retrospective review on medical records was performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: August 2017
• Est. primary completion date: November 30, 2016
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• confirmed clinical diagnosis of cerebral palsy based on neuromotor findings,

• less than 18 years of age,

• received recombinant human erythropoietin (rhEPO) more than once.

Exclusion Criteria:

• not responding to phone interview or

• no functional assessments available.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Drug:
• recombinant human erythropoietin
Subcutaneous rhEPO injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bundang CHA Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	telephone interview was conducted to collect information of adverse events from all patients.	interview was performed at an average of 1 year after the completion of rhEPO injections
Secondary	Change of Gross Motor Function Measure	The change of GMFM score before and after rhEPO injections	The results between the baseline evaluation before rhEPO injection and the last evaluation at an average of 1 year after rhEPO injections were compared