Testing a new treatment for ALS using erythropoietin
Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis
This study is testing whether a new treatment using erythropoietin can help people with early-stage ALS feel better and stay healthier.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 25 Years to 80 Years |
| Sex | All |
| Sponsor | Hanyang University Seoul Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT03835507 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of recombinant human erythropoietin (rhEPO) in patients with amyotrophic lateral sclerosis (ALS). It is a randomized, double-blind study that aims to determine the feasibility of high-dose rhEPO therapy in ALS patients who meet specific eligibility criteria. Participants will be monitored for safety and potential benefits over the course of the trial. The study focuses on individuals with early-stage ALS, specifically those with a disease duration of less than three years.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 80 with early-stage ALS and specific neurological signs.
Not a fit: Patients with advanced ALS, those requiring ventilatory support, or with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with ALS, potentially slowing disease progression.
How similar studies have performed: Previous studies have shown neuroprotective effects of erythropoietin in animal models of ALS, but this approach in humans is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Hanyang Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Jinseok Park, MD
- Email: jinseok.park0@gmail.com
- Phone: +82-2-2290-8367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.