Amyotrophic Lateral SclerosisPhase 1/2NCT03835507
Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis
A Phase 1/2 study testing recombinant human erythropoietin(rhEPO) in people with Amyotrophic Lateral Sclerosis, run by Hanyang University Seoul Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- recombinant human erythropoietin(rhEPO)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2016to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang Medical Center
Seoul
Jinseok Park, MD, +82-2-2290-8367, jinseok.park0@gmail.com
About this study
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- recombinant human erythropoietin(rhEPO)
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human erythropoietin(rhEPO)Drug
Injection of erythropoietin every months (total 12 months)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Inject Normal saline 100ml * 12 times (1month apart) Receives: Drug: recombinant human erythropoietin(rhEPO) |
| Low dose group | Experimental | Inject 500IU/kg of EPO mixed with normal saline 100ml * 12 times (1month apart) Receives: Drug: recombinant human erythropoietin(rhEPO) |
| High dose group | Experimental | Inject 750IU/kg of EPO mixed with normal saline 100ml * 12 times (1month apart) Receives: Drug: recombinant human erythropoietin(rhEPO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of ALSFRS-R score
changes between score of ALSFRS-R at initial and study end point
Measured: Last visit [15th visit (15 months)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start20 Jun 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung Hyun Kim, Hanyang University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835507
- Sponsor's protocol ID
- HYNR-EPO
- Status last verified
- Feb 2019
- First submitted
- 8 Aug 2018
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim HY, Moon C, Kim KS, Oh KW, Oh SI, Kim J, Kim SH. Recombinant human erythropoietin in amyotrophic lateral sclerosis: a pilot study of safety and feasibility. J Clin Neurol. 2014 Oct;10(4):342-7. doi: 10.3988/jcn.2014.10.4.342. Epub 2014 Oct 6.
PubMed 25324884Noh MY, Cho KA, Kim H, Kim SM, Kim SH. Erythropoietin modulates the immune-inflammatory response of a SOD1(G93A) transgenic mouse model of amyotrophic lateral sclerosis (ALS). Neurosci Lett. 2014 Jun 27;574:53-8. doi: 10.1016/j.neulet.2014.05.001. Epub 2014 May 10.
PubMed 24820540
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT03835507
- Acronym / sponsor ID
- HYNR-EPO
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: recombinant human erythropoietin(rhEPO)Inject Normal saline 100ml * 12 times (1month apart) |
| Low dose group | Experimental | Drug: recombinant human erythropoietin(rhEPO)Inject 500IU/kg of EPO mixed with normal saline 100ml * 12 times (1month apart) |
| High dose group | Experimental | Drug: recombinant human erythropoietin(rhEPO)Inject 750IU/kg of EPO mixed with normal saline 100ml * 12 times (1month apart) |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant human erythropoietin(rhEPO)Injection of erythropoietin every months (total 12 months) | Drug | Control group, High dose group, Low dose group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Results publication: PubMed 25324884Kim HY, Moon C, Kim KS, Oh KW, Oh SI, Kim J, Kim SH. Recombinant human erythropoietin in amyotrophic lateral sclerosis: a pilot study of safety and feasibility. J Clin Neurol. 2014 Oct;10(4):342-7. doi: 10.3988/jcn.2014.10.4.342. Epub 2014 Oct 6.
- Results publication: PubMed 24820540Noh MY, Cho KA, Kim H, Kim SM, Kim SH. Erythropoietin modulates the immune-inflammatory response of a SOD1(G93A) transgenic mouse model of amyotrophic lateral sclerosis (ALS). Neurosci Lett. 2014 Jun 27;574:53-8. doi: 10.1016/j.neulet.2014.05.001. Epub 2014 May 10.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing recombinant human erythropoietin(rhEPO) in people with Amyotrophic Lateral Sclerosis, run by Hanyang University Seoul Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinseok Park, MD (+82-2-2290-8367, jinseok.park0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of ALSFRS-R score (time frame: Last visit [15th visit (15 months)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03835507, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.