Safety and Tolerability of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis
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|ClinicalTrials.gov Identifier: NCT01277315|
Recruitment Status : Unknown
Verified January 2011 by Charite University, Berlin, Germany.
Recruitment status was: Recruiting
First Posted : January 14, 2011
Last Update Posted : February 28, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis (ALS)||Drug: Anakinra||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Safety and Tolerability Trial to Evaluate a Subcutaneous Injection Solution of 100 mg of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||June 2012|
- Drug: Anakinra
Open Safety and Tolerability study to evaluate a subcutaneous application 100 mg of Anakinra in combination with Riluzol in Amyotrophic Lateral Sclerosis.
- Number and Severity of adverse events (AE) [ Time Frame: 1 month ]
- Number and Severity of serious adverse events (SAE) [ Time Frame: 1 month ]
- Number and Severity of adverse drug reactions (ARD) [ Time Frame: 1 month ]
- Number and Severity of unexpected adverse drug reactions (UADR) [ Time Frame: 1 month ]
- Number and Severity of serious adverse drug reactions (SADR) [ Time Frame: 1 month ]
- Number and Severity of suspected unexpected serious adverse reaction (SUSAR) [ Time Frame: 1 month ]
- Pathological laboratory parameters [ Time Frame: 1 month ]
- Long Term Tolerability and Safety of Anakinra in ALS Patients [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277315
|Contact: Thomas Meyer, MDfirstname.lastname@example.org|
|Contact: Teresa Holm, MDemail@example.com|
|Principal Investigator:||Thomas Meyer, MD||Charité University Hospital, Berlin, Germany|