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Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT03835507
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Seung Hyun Kim, Hanyang University Seoul Hospital

Tracking Information
First Submitted Date  ICMJE August 8, 2018
First Posted Date  ICMJE February 8, 2019
Last Update Posted Date February 8, 2019
Actual Study Start Date  ICMJE June 20, 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
changes of ALSFRS-R score [ Time Frame: Last visit [15th visit (15 months)] ]
changes between score of ALSFRS-R at initial and study end point
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis
Official Title  ICMJE Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis
Brief Summary Erythropoietin is neuroprotective in animal models of neurodegenerative diseases including amyotrophic lateral sclerosis (ALS). The aim of this study was to determine the safety and feasibility of repetitive high-dose recombinant human erythropoietin (rhEPO) therapy in ALS patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE Drug: recombinant human erythropoietin(rhEPO)
Injection of erythropoietin every months (total 12 months)
Study Arms  ICMJE
  • Placebo Comparator: Control group
    Inject Normal saline 100ml * 12 times (1month apart)
    Intervention: Drug: recombinant human erythropoietin(rhEPO)
  • Experimental: Low dose group
    Inject 500IU/kg of EPO mixed with normal saline 100ml * 12 times (1month apart)
    Intervention: Drug: recombinant human erythropoietin(rhEPO)
  • Experimental: High dose group
    Inject 750IU/kg of EPO mixed with normal saline 100ml * 12 times (1month apart)
    Intervention: Drug: recombinant human erythropoietin(rhEPO)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2019)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 25 to 80
  • upper motor neuron signs and lower motor neuron signs were identified in neurological examination.
  • Meet the revised El Escorial Criteria for clinically possible, probable-laboratory -supported, probable, definite ALS.
  • Disease duration < 3 years (Within 3 years from symptom onset)
  • ALSFRS-R score between 21 to 46
  • Patient who can visit an outpatient under the aid of his or her own walking or caregivers.
  • The person who have agreed in writing to participate in this clinical trial by themselves and the legal representative
  • FVC over 50% at screening

Exclusion Criteria:

  • Person who were not compatible with ALS
  • Patient with PLS or PMA
  • A group of patients who are concerned about the adverse effects of the drug administration (e.g. malignant hypertension,...)
  • ALSFRS-R score below 20 at screening
  • Ventilator user or Tracheostomy state patients at screening
  • Gastrostomy state at screening
  • FVC below 50% at screening or patient who cannot perform FVC test.
  • EKG abnormality, history of coronary stent , CABG at screening
  • Person who was given another clinical trial drug three months prior to screening.
  • History of seizure/ epilepsy
  • Abnormal renal function (serem creatinine > 2.0mg/dl)
  • Abnormal liver function(AST/ALT/bilirubin over 2 times the upper normal limit
  • Pregnant
  • Bleeding tendency at screening
  • Infectious disease at screening
  • Drug sensitivity
  • Person who injected erythropoietin 6 months prior to screening
  • Malignant tumor
  • Other neurological disease (stroke, parkinson's disease, dementia...)
  • Psychological disease
  • Hb more than 16g/dL
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jinseok Park, MD +82-2-2290-8367 jinseok.park0@gmail.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03835507
Other Study ID Numbers  ICMJE HYNR-EPO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Seung Hyun Kim, Hanyang University Seoul Hospital
Study Sponsor  ICMJE Hanyang University Seoul Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hanyang University Seoul Hospital
Verification Date February 2019

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