Erythropoietin Therapy for Children With Cerebral Palsy
Random Control Trial to Evaluate the Safety and Efficacy of Erythropoietin Therapy for Children With Cerebral Palsy -Patient, Principle Investigator, Observer Blind
1 other identifier
interventional
11
1 country
1
Brief Summary
This randomized placebo-controlled trial aims to investigate the efficacy and safety of erythropoetin for children with cerebral palsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2012
CompletedFirst Posted
Study publicly available on registry
July 26, 2012
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedOctober 12, 2017
October 1, 2017
5 months
July 24, 2012
October 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Quality of Movement
GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones: alignment, coordination, dissociated movement, stability, and weight shift. The interrater reliability of GMPM subscores and total scores was 0.758-0.886 (subject n=75, tester n=10).
Baseline - 2 months
Secondary Outcomes (4)
Changes in Gross Motor Function
Baseline - 2 months
Changes in Neurodevelopmental Outcomes
Baseline - 2 months
Changes in Motor Development
Baseline - 2 months
Changes in Spasticity
Baseline - 2 months
Study Arms (2)
Erythropoietin and Rehabilitation
EXPERIMENTALrecombinant human erythropoietin injection and active rehabilitation
Placebo and Rehabilitation
PLACEBO COMPARATORPlacebo erythropoietin and rehabilitation
Interventions
Eligibility Criteria
You may qualify if:
- Cerebral Palsy
- Abnormal Muscle Tone
- Abnormal Brain MRI
- Willing to Comply with All Study Procedure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bundang CHA Hospitallead
- LG Life Sciencescollaborator
Study Sites (1)
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 463-712, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Minyoung Kim, M.D., Ph.D.
CHA University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 24, 2012
First Posted
July 26, 2012
Study Start
September 1, 2014
Primary Completion
February 1, 2015
Study Completion
December 1, 2015
Last Updated
October 12, 2017
Record last verified: 2017-10