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Erythropoietin Therapy for Children With Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01650415
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : October 12, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

July 24, 2012
July 26, 2012
October 12, 2017
September 2014
February 2015   (Final data collection date for primary outcome measure)
Changes in Quality of Movement [ Time Frame: Baseline - 2 months ]
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).
Changes in Quality of Movement [ Time Frame: Baseline - 2 months ]
GMPM (Gross Motor Perfomance 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).
Complete list of historical versions of study NCT01650415 on ClinicalTrials.gov Archive Site
  • Changes in Gross Motor Function [ Time Frame: Baseline - 2 months ]
    GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of 6 sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping. The measured interrater reliability of GMFM subscores and total scores was 0.974 - 0.997 (subject n=101, tester n=10) and intrarater reliability of GMFM subscores and total scores between one most experienced rater and another newly t rained rater was 0.994 - 1.000 (subject n=101, tester n=2).
  • Changes in Neurodevelopmental Outcomes [ Time Frame: Baseline - 2 months ]
    K-BSID-II (Korean version of Bayley Scale of Infant Development-II) Motor and Mental Scales. The measured intrarater and interrater reliability of K-BSID-II motor and mental scales was 0.92 - 0.99 (subject n=55, tester n=10).
  • Changes in Motor Development [ Time Frame: Baseline - 2 months ]
    AIMS (Alberta Infant Motor Scale)to measure the motor development
  • Changes in Spasticity [ Time Frame: Baseline - 2 months ]
    MAS (modified Ashworth Scale)measured at biceps, hip adductor, hamstring, heel cord
Same as current
Not Provided
Not Provided
 
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
This randomized placebo-controlled trial aims to investigate the efficacy and safety of erythropoetin for children with cerebral palsy.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cerebral Palsy
  • Drug: Erythropoietin
    twice a week for 1 month
    Other Name: Espogen
  • Drug: Placebo erythropoietin
    twice a week for 1 month
  • Experimental: Erythropoietin and Rehabilitation
    recombinant human erythropoietin injection and active rehabilitation
    Intervention: Drug: Erythropoietin
  • Placebo Comparator: Placebo and Rehabilitation
    Placebo erythropoietin and rehabilitation
    Intervention: Drug: Placebo erythropoietin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
December 2015
February 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
4 Months to 4 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01650415
CPEPO
No
Not Provided
Not Provided
MinYoung Kim, M.D., Bundang CHA Hospital
Bundang CHA Hospital
LG Life Sciences
Principal Investigator: Minyoung Kim, M.D., Ph.D. CHA University
Bundang CHA Hospital
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP