Erythropoietin Therapy for Children With Cerebral Palsy: Phase 1
NCT ID: NCT01586052
Last Updated: 2014-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
11 participants
INTERVENTIONAL
2012-06-30
2013-10-31
Brief Summary
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Detailed Description
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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, and anti-inflammation.
On the basis of many experimental studies, erythropoietin is suggested as a potential therapy for cerebral palsy.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Erythropoietin and Rehabilitation
recombinant human erythropoietin injection and active rehabilitation
Erythropoietin
250 IU/kg, Twice a week for 4 weeks
Interventions
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Erythropoietin
250 IU/kg, Twice a week for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Abnormal Muscle Tone
* GMFCS (Gross Motor Functional Classification System): II to IV
* Age: 6 months \~ 3 years
* Abnormal Brain MRI compatible to clinical features and non-progressive
* Willing to Comply with All Study Procedure
Exclusion Criteria
* Baseline Erythropoietin level \> 45 mU/mL
* Presence of Drug Hypersensitivity Related to the Study Remedy
* Previous Erythropoietin Treatment before 3 months
* Coagulopathy:
Family History, Unknown Cerebral Infarction, Thromboembolic Events History
* Intractable Seizure Disorder
* Poor Cooperation of Guardian including Inactive Attitude for Rehabilitation
* Uncontrolled Hypertension
* Liver Dysfunction
* Renal Dysfunction
* Absolute Neutrophil Count \< 500/dL
* Intracerebral or Intraventricular Hemorrhage
* Malignancy
6 Months
3 Years
ALL
No
Sponsors
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LG Life Sciences
INDUSTRY
MinYoung Kim, M.D.
OTHER
Responsible Party
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MinYoung Kim, M.D.
Associate Professor
Principal Investigators
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Minyoung Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
CHA University
Locations
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CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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CPEPOPhase1
Identifier Type: -
Identifier Source: org_study_id
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