Evidence map›Paper›PMID 30458059›Full record

ArticleMuscle & nerve2019

A pilot trial of RNS60 in amyotrophic lateral sclerosis.

Sabrina Paganoni, Mohamad J Alshikho, Sarah Luppino, James Chan, Lindsay Pothier, David Schoenfeld, Patricia L Andres, Suma Babu, Nicole R Zürcher, Marco L Loggia and 12 more

Abstract read
In one paragraph

Article in Muscle & nerve, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

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  11. [Molecular psychiatry · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Sabrina PaganoniNeurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
Mohamad J AlshikhoNeurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
Sarah LuppinoNeurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
James ChanMassachusetts General Hospital Biostatistics Center, Boston, Massachusetts, USA.
Lindsay PothierNeurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
David SchoenfeldMassachusetts General Hospital Biostatistics Center, Boston, Massachusetts, USA.
Patricia L AndresNeurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
Suma BabuNeurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
Nicole R ZürcherAthinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Marco L LoggiaAthinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Robert L BarryAthinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Silvia LuottiIRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.
Giovanni NardoIRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.
Maria Chiara TroleseIRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.
Serena PantaloneIRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.
Caterina BendottiIRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.
Valentina BonettoIRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.
Fabiola De MarchiNeurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
Bruce RosenAthinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Jacob HookerAthinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Merit CudkowiczNeurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
Nazem AtassiNeurological Clinical Research Institute, Massachusetts General Hospital, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.

Funding

Molecular Imaging of Inflammation in Amyotrophic Lateral Sclerosis (ALS)K23NS083715 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI ATASSI, NAZEM · 2014 to 2018
$927k
Carbon-11 Automation Equipment for Human PET Radiotracer ProductionS10OD023517 · OD · MASSACHUSETTS GENERAL HOSPITAL · PI HOOKER, JACOB M. · 2018 to 2018
$502k
Carbon-11 Radiopharmaceutical Production SystemS10RR026666 · NCRR · MASSACHUSETTS GENERAL HOSPITAL · PI BROWNELL, ANNA-LIISA · 2010 to 2010
$462k
MGH ALS Therapy FundNCRR NIH HHS S10 RR026666NIH HHS S10 OD023517NINDS NIH HHS K23 NS083715
6 · The paper itself

Abstract

introductionRNS60 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.

methodsThe 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.

resultsSixteen 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 59:303-308, 2019.

Indexed as

Administration, InhalationAdultAgedAmyotrophic Lateral SclerosisAnti-Inflammatory Agents, Non-SteroidalBiomarkersBrainFemaleHealthy VolunteersHumansInfusions, IntravenousMaleMiddle AgedMuscle StrengthNeuroimagingPilot ProjectsAnti-Inflammatory Agents, Non-SteroidalBiomarkersRNS60Sodium ChlorideALSclinical trialmotor neuron disease (MND)neuroinflammationPBR28

Identifiers

PMID30458059
PMCPMC6379136

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.