A pilot trial of RNS60 in amyotrophic lateral sclerosis.
Muscle Nerve
; 59(3): 303-308, 2019 03.
Article
en En
| MEDLINE
| ID: mdl-30458059
ABSTRACT
INTRODUCTION:
RNS60 is a novel immune-modulatory agent that has shown neuroprotective effects in amytrophic lateral sclerosis (ALS) preclinical models. RNS60 is administered by weekly intravenous infusion and daily nebulization. The objective of this pilot open-label trial was to test the feasibility, safety, and tolerability of long-term RNS60 administration in ALS patients.METHODS:
The planned treatment duration was 23 weeks and the primary outcomes were safety and tolerability. Secondary outcomes included PBR28 positron emission tomography (PET) imaging and plasma biomarkers of inflammation.RESULTS:
Sixteen participants with ALS received RNS60 and 13 (81%) completed 23 weeks of RNS60 treatment. There were no serious adverse events and no participants withdrew from the trial due to drug-related adverse events. There were no significant changes in the biomarkers.DISCUSSION:
Long-term RNS60 administration was safe and well-tolerated. A large, multicenter, phase II trial of RNS60 is currently enrolling participants to test the effects of RNS60 on ALS biomarkers and disease progression. Muscle Nerve 59303-308, 2019.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Antiinflamatorios no Esteroideos
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Esclerosis Amiotrófica Lateral
Límite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Muscle Nerve
Año:
2019
Tipo del documento:
Article
País de afiliación:
Estados Unidos