DRKS00030948
Recruiting
Phase 2
B-cell depletion for the treatment of patients with amyotrophic lateral sclerosis (ALS) - A Randomized, Double-blind, Placebo controlled Pilot Study in Patients with Amyotrophic Lateral Sclerosis for the Evaluation of Efficacy and Safety of B-Cell Depletion with Rituximab (ABCD) - ABCD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- G12.2
- Sponsor
- Deutsches Zentrum für Neurodegenerative Erkrankungen e.v.
- Enrollment
- 65
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Disease duration of sporadic ALS is \= 24 months after symptom onset and symptoms have not progressed to a permanent need of assisted ventilation of any kind (including non\-invasive ventilation).
- •Written consent to participate in the study
- •Patients with the capacity to give informed consent
- •The patient is capable to attend study visits
- •Medication with riluzole at a stable dose of 50 mg BID for \= 30 days prior to the screening visit and if possible, throughout the study.
- •Slow vital capacity (VC) equal to or more than 75% of the predicted normal value for gender, height and age at the screening visit
- •Recommended vaccination according to STIKO (incl. COVID\-19 vaccination)
Exclusion Criteria
- •Dysfunction (other than ALS) that could distort or obscure the diagnosis of ALS
- •Patients with a tracheostomy or ongoing treatment (more than 7 consecutive days in the 4 weeks prior to the screening visit) requiring noninvasive positive pressure ventilation of any kind
- •Patients with HIV infections
- •Active, severe infections (e.g. tuberculosis, sepsis and opportunistic infections)
- •History of chronically active hepatitis including active or chronic hepatitis B, acute or chronic hepatitis C
- •History of a tuberculosis (TB) infection, signs/symptoms of TB or close contact with a person with an active TB infection
- •Clinically significant infection involving intravenous administration of antibiotics and hospitalization in the 4 weeks prior to the screening visit
- •Patients with a serious impairment of the immune system
- •Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled heart disease
- •Patients having severe disease in the renal, cardiovascular or hematological system
Outcomes
Primary Outcomes
Not specified
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