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

NCT03835507 Phase 1/Phase 2 UNKNOWN

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.

Details

Lead sponsor	Hanyang University Seoul Hospital
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	64
Start date	2016-06-20
Completion	2025-12

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

• recombinant human erythropoietin(rhEPO)

Primary outcomes

• changes of ALSFRS-R score — Last visit [15th visit (15 months)]
  changes between score of ALSFRS-R at initial and study end point

Countries

South Korea