Trial record 19 of 124 for:    Open Studies | "Cerebral Palsy"

Erythropoietin Therapy for Children With Cerebral Palsy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Bundang CHA Hospital
Sponsor:
Collaborator:
LG Life Sciences
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital
ClinicalTrials.gov Identifier:
NCT01650415
First received: July 24, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Cerebral Palsy
Drug: Erythropoietin
Drug: Placebo erythropoietin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Bundang CHA Hospital:

Primary Outcome Measures:
  • Changes in Quality of Movement [ Time Frame: Baseline - 2 months ] [ Designated as safety issue: No ]
    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:
  • Changes in Gross Motor Function [ Time Frame: Baseline - 2 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    AIMS (Alberta Infant Motor Scale)to measure the motor development

  • Changes in Spasticity [ Time Frame: Baseline - 2 months ] [ Designated as safety issue: No ]
    MAS (modified Ashworth Scale)measured at biceps, hip adductor, hamstring, heel cord


Estimated Enrollment: 80
Study Start Date: September 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   4 Months to 4 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650415

Contacts
Contact: Minyoung Kim, M.D., Ph.D. 82-31-780-1872 kmin@cha.ac.kr
Contact: Kyunghoon Min, M.D. 82-10-8973-3732 minkh@chamc.co.kr

Locations
Korea, Republic of
CHA Bundang Medical Center, CHA University Not yet recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Contact: Minyoung Kim, M.D., Ph.D.    82-31-780-1872    kmin@cha.ac.kr   
Contact: Kyunghoon Min, M.D.    82-10-8973-3732    minkh@chamc.co.kr   
Sub-Investigator: Kyunghoon Min, M.D.         
Sub-Investigator: Junyoung Song, M.D.         
Sponsors and Collaborators
Bundang CHA Hospital
LG Life Sciences
Investigators
Principal Investigator: Minyoung Kim, M.D., Ph.D. CHA University
  More Information

No publications provided

Responsible Party: MinYoung Kim, M.D., Associate Professor, Bundang CHA Hospital
ClinicalTrials.gov Identifier: NCT01650415     History of Changes
Other Study ID Numbers: CPEPO
Study First Received: July 24, 2012
Last Updated: March 31, 2014
Health Authority: Korea: Korea Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by Bundang CHA Hospital:
Cerebral Palsy
Erythropoietin
Rehabilitation

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014