Clinical trial: Safety and Tolerability of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis (NCT01277315)

Eligibility criteria:
Inclusion Criteria:

          -  Patients between 18 and 80 years of age

          -  Clinical diagnosis of amyotrophic lateral sclerosis with predominant affection of the
             lower motor neuron or the clinical ALS variant of progressive muscular atrophy (PMA)

          -  Clinical signs of lower motor neuron degeneration in at least one anatomic region
             beyond the brain stem

          -  Sporadic and familial ALS

          -  Onset of paresis six months to four years before study inclusion

          -  Treatment with riluzol 100mg/d at least 1 month before study inclusion

        Exclusion Criteria:

          -  Diagnosis of amyotrophic lateral sclerosis with predominant affection or the upper
             motor neuron without clinical signs of a concurrent affection of the lower motor
             neuron in at least one anatomic region beyond the brain stem (spastic ALS) - Diagnosis
             of primary lateral sclerosis (PLS)

          -  Patients with known intolerance to anakinra, riluzol or one of the additives

          -  Clinically severe hypoventilation syndrome with vital capacity < 50%

          -  Pregnancy or breastfeeding

          -  Continuous non-invasive ventilation with ventilator-free time < 2 hours - Tracheotomy
             and mechanical ventilation

          -  Laboratory parameters outside the normal range that correspond to a clinically severe
             cardiovascular, pulmological, hematological, hepatological, metabolic or renal disease

          -  Malignancies

          -  Severe renal insufficiency (creatinine clearance < 30 ml/min)

          -  History of recurrent infections or a disease that may predispose to infections

          -  Severe neutropenia (absolute neutrophil count < 1.5 x 109/l)

          -  Monoclonal gammopathy of unknown significance

          -  Infections including infections with HIV and hepatitis B and C

          -  Dementia and unable to give informed consent

          -  History of epilepsy and epileptic seizures

          -  Contraindication to E coli-derived proteins, anakinra or any components of the product

          -  Concurrent therapy of anakinra and etanercept or other TNF blocking agents
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment