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Erythropoietin Therapy for Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT01650415
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : October 12, 2017
Sponsor:
Collaborator:
LG Life Sciences
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital

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

Condition or disease Intervention/treatment Phase
Cerebral Palsy Drug: Erythropoietin Drug: Placebo erythropoietin Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Erythropoietin and Rehabilitation
recombinant human erythropoietin injection and active rehabilitation
 Drug: Erythropoietin
twice a week for 1 month
Other Name: Espogen
Placebo Comparator: Placebo and Rehabilitation
Placebo erythropoietin and rehabilitation
 Drug: Placebo erythropoietin
twice a week for 1 month


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  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).

  3. Changes in Motor Development [ Time Frame: Baseline - 2 months ]
    AIMS (Alberta Infant Motor Scale)to measure the motor development

  4. Changes in Spasticity [ Time Frame: Baseline - 2 months ]
    MAS (modified Ashworth Scale)measured at biceps, hip adductor, hamstring, heel cord


Eligibility Criteria
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Ages Eligible for Study:   4 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650415


Locations
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Korea, Republic of
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Sponsors and Collaborators
Bundang CHA Hospital
LG Life Sciences
Investigators
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Principal Investigator: Minyoung Kim, M.D., Ph.D. CHA University
More Information
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Responsible Party: MinYoung Kim, M.D., Associate Professor, Bundang CHA Hospital
ClinicalTrials.gov Identifier: NCT01650415    
Other Study ID Numbers: CPEPO
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Keywords provided by MinYoung Kim, M.D., Bundang CHA Hospital:
Cerebral Palsy
Erythropoietin
Rehabilitation
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
 Brain Diseases
Central Nervous System Diseases
Epoetin Alfa
Hematinics