Evidence map›Paper›PMID 33908635›Full record

Trial reportJournal of clinical pharmacology2021

Longitudinal Impact of Acute Spinal Cord Injury on Clinical Pharmacokinetics of Riluzole, a Potential Neuroprotective Agent.

Ashley Nguyen, Diana S-L Chow, Lei Wu, Yang Angela Teng, Mahua Sarkar, Elizabeth G Toups, James S Harrop, Karl M Schmitt, Michele M Johnson, James D Guest and 6 more

Open access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 35% 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.

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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Edema after CNS Trauma: A Focus on Spinal Cord Injury.International journal of molecular sciences · 2023
    Review
  3. Pathophysiology and Therapeutic Approaches for Spinal Cord Injury.International journal of molecular sciences · 2022
    Review
  4. Review
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

16 authors at 10 institutions in 2 countries.

Ashley NguyenDepartment of Pharmacological and Pharmaceutical Sciences, College of Pharmacy, University of Houston, Houston, Texas, USA.
Diana S-L ChowDepartment of Pharmacological and Pharmaceutical Sciences, College of Pharmacy, University of Houston, Houston, Texas, USA.
Lei WuDepartment of Pharmacological and Pharmaceutical Sciences, College of Pharmacy, University of Houston, Houston, Texas, USA.
Yang Angela TengDepartment of Pharmacological and Pharmaceutical Sciences, College of Pharmacy, University of Houston, Houston, Texas, USA.
Mahua SarkarDepartment of Pharmacological and Pharmaceutical Sciences, College of Pharmacy, University of Houston, Houston, Texas, USA.
Elizabeth G ToupsDepartment of Neurosurgery, Houston Methodist Research Institute, Houston, Texas, USA.
James S HarropDepartment of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Karl M SchmittDepartment of Neurosurgery, Health Science Center, University of Texas, Houston, Texas, USA.
Michele M JohnsonDepartment of Neurosurgery, Health Science Center, University of Texas, Houston, Texas, USA.
James D GuestDepartment of Neurological Surgery, Miller School of Medicine, University of Miami, Miami, Florida, USA.
Bizhan AarabiDepartment of Neurosurgery, University of Maryland, Baltimore, Maryland, USA.
Christopher I ShaffreyDepartment of Neurosurgery, University of Virginia Health System, Charlottesville, Virginia, USA.
Maxwell BoakyeDepartment of Neurosurgery, University of Louisville, Louisville, Kentucky, USA.
Ralph F FrankowskiLate colleague, Division of Biostatistics, University of Texas School of Public Health, Houston, Texas, USA.
Michael G FehlingsDivision of Neurosurgery and Spine Program, Toronto Western Hospital, University of, Toronto, Ontario, Canada.
Robert G GrossmanDepartment of Neurosurgery, Houston Methodist Research Institute, Houston, Texas, USA.
University of Houston · USHouston Methodist · USThe University of Texas Health Science Center at Houston · USDuke Medical Center · USThe University of Texas Health Science Center · USThomas Jefferson University · USToronto Western Hospital · CAUniversity of Louisville · USUniversity of Maryland, Baltimore · USUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Riluzole, a benzothiazole sodium channel blocker that received US Food and Drug Administration approval to attenuate neurodegeneration in amyotrophic lateral sclerosis in 1995, was found to be safe and potentially efficacious in a spinal cord injury (SCI) population, as evident in a phase I clinical trial. The acute and progressive nature of traumatic SCI and the complexity of secondary injury processes can alter the pharmacokinetics of therapeutics. A 1-compartment with first-order elimination population pharmacokinetic model for riluzole incorporating time-dependent clearance and volume of distribution was developed from combined data of the phase 1 and the ongoing phase 2/3 trials. This change in therapeutic exposure may lead to a biased estimate of the exposure-response relationship when evaluating therapeutic effects. With the developed model, a rational, optimal dosing scheme can be designed with time-dependent modification that preserves the required therapeutic exposure of riluzole.

Indexed as

Clinical Trials, Phase I as TopicDose-Response Relationship, DrugDouble-Blind MethodHalf-LifeHumansMetabolic Clearance RateModels, BiologicalNeuroprotective AgentsRiluzoleSpinal Cord InjuriesTime FactorsNeuroprotective AgentsRiluzolepharmacokineticspopulation modelingriluzolespinal cord injury

Identifiers

PMID33908635
PMCPMC8457124
OpenAlexW3157957845

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.