Evidence map›Paper›PMID 28662296›Full record

Trial reportMuscle & nerve2017

Phase IIa trial of fingolimod for amyotrophic lateral sclerosis demonstrates acceptable acute safety and tolerability.

James D Berry, Sabrina Paganoni, Nazem Atassi, Eric A Macklin, Namita Goyal, Michael Rivner, Ericka Simpson, Stanley Appel, Daniela L Grasso, Nicte I Mejia and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Muscle & nerve, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06639282 (SIPO1-AD), which is not on this map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
–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.

NCT06639282 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

SIPO1-AD: A Phase II Clinical Trial for the Assessment of Safety, Tolerability, and Efficacy of Siponimod in Patients With Mild Alzheimer's Disease

TypeinterventionalSponsorSt. Joseph's Hospital and Medical Center, PhoenixRan2025 to 2029Enrolled105ConditionsAlzheimer Disease, Mild Alzheimer Disease, MCI With Increased Risk for Alzheimer Disease, Cognitive Impairment, MildArmsSiponimod, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  8. Therapeutic targeting of ALS pathways: Refocusing an incomplete picture.Annals of clinical and translational neurology · 2023
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  11. A Novel Drosophila-based Drug Repurposing Platform Identified Fingolimod As a Potential Therapeutic for TDP-43 Proteinopathy.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
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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

15 authors.

James D BerryNeurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
Sabrina PaganoniNeurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
Nazem AtassiNeurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
Eric A MacklinNeurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
Namita GoyalDepartment of Neurology, University of California, Irvine, Orange, California, USA.
Michael RivnerDepartment of Neurology, Augusta University Medical Center, Augusta, Georgia, USA.
Ericka SimpsonDepartment of Neurology, Methodist Hospital, Houston, Texas, USA.
Stanley AppelDepartment of Neurology, Methodist Hospital, Houston, Texas, USA.
Daniela L GrassoNeurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
Nicte I MejiaNeurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
Farrah MateenNeurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, 165 Cambridge Street, Suite 600, Boston, Massachusetts, 02114, USA.
Alan GillALS Therapy Development Institute, Cambridge, Massachusetts, USA.
Fernando VieiraALS Therapy Development Institute, Cambridge, Massachusetts, USA.
Valerie TassinariALS Therapy Development Institute, Cambridge, Massachusetts, USA.
Steven PerrinALS Therapy Development Institute, Cambridge, Massachusetts, USA.

Funding

University of California Health Participation in the National COVID Cohort Collaborative (N3C)UL1TR001414 · NCATS · UNIVERSITY OF CALIFORNIA-IRVINE · PI COOPER, DAN M, VILAIN, ERIC J. · 2015 to 2023
$35.1M
NCATS NIH HHS UL1 TR001414
6 · The paper itself

Abstract

introductionImmune activation has been implicated in progression of amytrophic lateral sclerosis (ALS). Oral fingolimod reduces circulating lymphocytes. The objective of this phase IIa, randomized, controlled trial was to test the short-term safety, tolerability, and target engagement of fingolimod in ALS.

methodsRandomization was 2:1 (fingolimod:placebo). Treatment duration was 4 weeks. Primary outcomes were safety and tolerability. Secondary outcomes included circulating lymphocytes and whole-blood gene expression.

resultsThirty participants were randomized; 28 were administered a drug (fingolimod 18, placebo 10). No serious adverse events occurred. Adverse events were similar by treatment arm, as was study discontinuation (2 fingolimod vs. 0 placebo, with no statistical difference). Forced expiratory volume in 1 second (FEV DISCUSSION: Fingolimod is safe and well-tolerated and can reduce circulating lymphocytes in ALS patients. Muscle Nerve 56: 1077-1084, 2017.

Indexed as

AdultAgedAmyotrophic Lateral SclerosisBradycardiaFatigueFemaleFingolimod HydrochlorideHumansImmunosuppressive AgentsMaleMiddle AgedSingle-Blind MethodFingolimod HydrochlorideImmunosuppressive Agentscirculating lymphocytesclinical trialFOXP3neuroinflammationRNA profilingtarget engagement

Identifiers

PMID28662296
PMCPMC5724488

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.