Open Safety and Tolerability Trial to Evaluate a Subcutaneous Injection Solution of 100 mg of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis

NCT01277315 Phase 2 COMPLETED

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.

Details

Lead sponsor	Charite University, Berlin, Germany
Phase	Phase 2
Status	COMPLETED
Enrolment	20
Start date	2011-02
Completion	2012-06

Conditions

• Amyotrophic Lateral Sclerosis (ALS)

Interventions

• Anakinra

Primary outcomes

• Number and Severity of adverse events (AE) — 1 month
• Number and Severity of serious adverse events (SAE) — 1 month
• Number and Severity of adverse drug reactions (ARD) — 1 month
• Number and Severity of unexpected adverse drug reactions (UADR) — 1 month
• Number and Severity of serious adverse drug reactions (SADR) — 1 month
• Number and Severity of suspected unexpected serious adverse reaction (SUSAR) — 1 month

Countries

Germany