Erythropoietin Therapy for Children With Cerebral Palsy
This study is not yet open for participant recruitment.
Verified February 2013 by Bundang CHA Hospital
Sponsor:
Bundang CHA Hospital
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: February 4, 2013
Last verified: February 2013
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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: | January 2014 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (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;
- Neuroprotection effect
- Angiogenesis
- 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
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 Bundang Medical center, 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: | February 4, 2013 |
| 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 Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations |
Signs and Symptoms Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013