Offene Verträglichkeitsstudie zur Evaluierung einer subkutanen Injektionslösung von 100 mg Anakinra in Kombination mit Riluzol bei Patienten mit Amyotropher Lateralsklerose (ALS). - Anakinra in ALS

Charité - University Hospital of Berlin0 个研究点开始时间: 2010年12月22日最近更新: 2013年8月26日

试验速览

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•- 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 atophy (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 3 month before study inclusion
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- 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 tubercolosis, 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

发起方

Charité - University Hospital of Berlin