Safety and Tolerability of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Amyotrophic Lateral Sclerosis (ALS) is an adult neurodegenerative disease that is caused by a
selective degeneration of the motor nerve cells in the cortex and myelon. As a result of
motor neurodegeneration, a progredient paralysis of the extremities and of the speaking,
swallowing, and breathing musculature develops. ALS leads to death by respiratory
insufficiency in a mean course of 3-5 years. So far, Riluzole is the only approved
neuroprotective medication which effects a slight lifespan prolongation of 1.5 - 2.5 months.
Riluzole inhibits the presynaptic glutamate release and lowers the level of glutamate
liberated by activated microglia.
The researchers propose an investigational therapy of ALS with subcutaneous administration of
100 mg of Anakinra. The neuronal inflammation is a crucial pathogenetic factor of the motor
neuron degeneration. Inflammatory processes are detectable in sporadic ALS, in the
autosomal-dominant form of ALS and in transgenic mouse model. The rationale of this clinical
trial is based on the anti-inflammatory effect of Anakinra. One of the key mediators of
inflammatory response is Interleukin-1. Anakinra is a recombinant produced Interleukin-1
receptor antagonist. This gives Anakinra anti-inflammatory attributes that presumably reduce
motor neuron degeneration and disease progression.