Evidence map›Paper›PMID 36662869›Full record

ArticlePloS one2023

Riluzole for treating spasticity in patients with chronic traumatic spinal cord injury: Study protocol in the phase ib/iib adaptive multicenter randomized controlled RILUSCI trial.

Maëva Cotinat, Isabelle Boquet, Moreno Ursino, Cécile Brocard, Elisabeth Jouve, Corinne Alberti, Laurent Bensoussan, Jean-Michel Viton, Frédéric Brocard, Olivier Blin

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02859792 (Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.0field-weighted citation impact, top 14% of its field
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.

NCT02859792 phase2unknown statusnot on this map

Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition: Adaptive, Multicenter, Placebo-controlled, Randomised, Double Blind Trial in a Rare Disorder

TypeinterventionalSponsorAssistance Publique Hopitaux De MarseilleRan2019 to 2023Enrolled90ConditionsSpinal Cord InjuryArmsRiluzole, Placebo, Blood Samples
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 13 citations in OpenAlex.

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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

10 authors at 3 institutions in 1 country.

Maëva CotinatInstitut de Neurosciences de la Timone (UMR7289), Aix-Marseille Université and CNRS, Marseille, France.ORCID 0000-0002-2500-1224
Isabelle BoquetInstitut de Neurosciences de la Timone (UMR7289), Aix-Marseille Université and CNRS, Marseille, France.ORCID 0000-0002-2028-5846
Moreno UrsinoUnit of Clinical Epidemiology, Assistance Publique-Hôpitaux de Paris, Centre Hospitalier Universitaire Robert Debré, FCRIN PARTNERS Platform, Université de Paris, Sorbonne Paris-Cité, INSERM U1123 and CIC-EC 1426, Paris, France.
Cécile BrocardInstitut de Neurosciences de la Timone (UMR7289), Aix-Marseille Université and CNRS, Marseille, France.
Elisabeth JouveAix Marseille University, APHM, INSERM, Inst Neurosci Syst, UMR1106, Service de Pharmacologie Clinique et Pharmacovigilance, Marseille, France.
Corinne AlbertiUnit of Clinical Epidemiology, Assistance Publique-Hôpitaux de Paris, Centre Hospitalier Universitaire Robert Debré, FCRIN PARTNERS Platform, Université de Paris, Sorbonne Paris-Cité, INSERM U1123 and CIC-EC 1426, Paris, France.
Laurent BensoussanInstitut de Neurosciences de la Timone (UMR7289), Aix-Marseille Université and CNRS, Marseille, France.
Jean-Michel VitonInstitut de Neurosciences de la Timone (UMR7289), Aix-Marseille Université and CNRS, Marseille, France.
Frédéric BrocardInstitut de Neurosciences de la Timone (UMR7289), Aix-Marseille Université and CNRS, Marseille, France.
Olivier BlinAix Marseille University, APHM, INSERM, Inst Neurosci Syst, UMR1106, Service de Pharmacologie Clinique et Pharmacovigilance, Marseille, France.
Centre National de la Recherche Scientifique · FRInserm · FRInstitut national de recherche en sciences et technologies du numérique · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSatisfactory treatment is often lacking for spasticity, a highly prevalent motor disorder in patients with spinal cord injury (SCI). Low concentrations of riluzole potently reduce the persistent sodium current, the post-SCI increase in which contributes to spasticity. The repurposing of this drug may therefore constitute a useful potential therapeutic option for relieving SCI patients suffering from chronic traumatic spasticity.

objectiveRILUSCI is a phase 1b-2b trial designed to assess whether riluzole is a safe and biologically effective means of managing spasticity in adult patients with traumatic chronic SCI.

methodsIn this multicenter double-blind trial, adults (aged 18-65 years) suffering from spasticity after SCI (target enrollment: 90 participants) will be randomly assigned to be given either a placebo or a recommended daily oral dose of riluzole for two weeks. The latter dose will be previously determined in phase 1b of the study by performing double-blind dose-finding tests using a Bayesian continuous reassessment method. The primary endpoint of the trial will be an improvement in the Modified Ashworth Score (MAS) or the Numerical Rating Score (NRS) quantifying spasticity. The secondary outcomes will be based on the safety and pharmacokinetics of riluzole as well as its impact on muscle spasms, pain, bladder dysfunction and quality of life. Analyses will be performed before, during and after the treatment and the placebo-controlled period.

conclusionTo the best of our knowledge, this clinical trial will be the first to document the safety and efficacy of riluzole as a means of reducing spasticity in patients with chronic SCI.

trial registrationThe clinical trial, which is already in progress, was registered on the ClinicalTrials.gov website on August 9, 2016 under the registration number NCT02859792. TRIAL SPONSOR: Assistance Publique-Hôpitaux de Marseille.

Indexed as

RiluzoleSpinal Cord InjuriesAdultBayes TheoremClinical Trials, Phase I as TopicDouble-Blind MethodHumansMulticenter Studies as TopicMuscle SpasticityQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeRiluzole

Identifiers

PMID36662869
PMCPMC9858801
OpenAlexW4317600717

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.