Amyotophic lateral sclerosis
Conditions
Interventions
Trade Name: Kineret
Product Name: Anakinra
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ANAKINRA
CAS Number: 143090-92-0
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Charité - University Hospital of Berlin
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety and tolerability of Anakinra in combination with Riluzol in amyotrophic lateral sclerosis;Secondary Objective: Evaluation of clinical efficacy of Anakinra in amyotrophic lateral sclerosis;Primary end point(s): An investigation of number and severity of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ARD), unexpected adverse drug reactions (UADR), serious adverse drug reactions (SADR), suspected unexpected serious adverse reaction (SUSAR) and pathological laboratory parameters | — |
Countries
Germany
Outcome results
None listed