Evidence map›Paper›PMID 22715372›Full record

Trial reportPloS one2012

A randomized, double blind, placebo-controlled trial of pioglitazone in combination with riluzole in amyotrophic lateral sclerosis.

Luc Dupuis, Reinhard Dengler, Michael T Heneka, Thomas Meyer, Stephan Zierz, Jan Kassubek, Wilhelm Fischer, Franziska Steiner, Eva Lindauer, Markus Otto and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00690118 (Efficacy, Safety and Tolerability Study of 45 mg Pioglitazone in Patients With Amyotrophic Lateral Sclerosis), which is not on this map. Cited by 71 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 4 pooled it
7.2field-weighted citation impact, top 3% 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.

NCT00690118 phase2terminatednot on this map

Efficacy, Safety and Tolerability Study of 45 mg Pioglitazone in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole)

TypeinterventionalSponsorUniversity of UlmRan2008 to 2010Enrolled219ConditionsAmyotrophic Lateral SclerosisArmspioglitazone, placebo
3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 4 syntheses or guidelines pooled it, 146 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Treatment of fatigue in amyotrophic lateral sclerosis/motor neuron disease.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Pooled it
  5. Trial
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  9. Article
  10. Article
  11. Article
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  14. Article
  15. Therapeutic targeting of ALS pathways: Refocusing an incomplete picture.Annals of clinical and translational neurology · 2023
    Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Altered Bioenergetics and Metabolic Homeostasis in Amyotrophic Lateral Sclerosis.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review

11 more citing papers are in PubMed but not listed here.

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

21 authors at 14 institutions in 2 countries.

Luc DupuisDepartment of Neurology, University of Ulm, Ulm, Germany.
Reinhard Dengler
Michael T Heneka
Thomas Meyer
Stephan Zierz
Jan Kassubek
Wilhelm Fischer
Franziska Steiner
Eva Lindauer
Markus Otto
Jens Dreyhaupt
Torsten Grehl
Andreas Hermann
Andrea S Winkler
Ulrich Bogdahn
Reiner Benecke
Bertold Schrank
Carsten Wessig
Julian Grosskreutz
Albert C Ludolph
GERP ALS Study Group
Universität Ulm · DECharité - Universitätsmedizin Berlin · DEDeutsche Klinik für Diagnostik · DEJena University Hospital · DEMartin Luther University Halle-Wittenberg · DEMedizinische Hochschule Hannover · DERuhr University Bochum · DETechnical University of Munich · DETU Dresden · DEUniversity of Bonn · DEUniversity of Regensburg · DEUniversity of Rostock · DEUniversity of Würzburg · DEZimmer Biomet (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPioglitazone, an oral anti-diabetic that stimulates the PPAR-gamma transcription factor, increased survival of mice with amyotrophic lateral sclerosis (ALS). METHODS/PRINCIPAL

findingsWe performed a phase II, double blind, multicentre, placebo controlled trial of pioglitazone in ALS patients under riluzole. 219 patients were randomly assigned to receive 45 mg/day of pioglitazone or placebo (one: one allocation ratio). The primary endpoint was survival. Secondary endpoints included incidence of non-invasive ventilation and tracheotomy, and slopes of ALS-FRS, slow vital capacity, and quality of life as assessed using EUROQoL EQ-5D. The study was conducted under a two-stage group sequential test, allowing to stop for futility or superiority after interim analysis. Shortly after interim analysis, 30 patients under pioglitazone and 24 patients under placebo had died. The trial was stopped for futility; the hazard ratio for primary endpoint was 1.21 (95% CI: 0.71-2.07, p = 0.48). Secondary endpoints were not modified by pioglitazone treatment. Pioglitazone was well tolerated. CONCLUSION/SIGNIFICANCE: Pioglitazone has no beneficial effects on the survival of ALS patients as add-on therapy to riluzole.

trial registrationClinicaltrials.gov NCT00690118.

Indexed as

AgedAmyotrophic Lateral SclerosisAnimalsAnticonvulsantsDisease-Free SurvivalDouble-Blind MethodDrug Therapy, CombinationFemaleHumansHypoglycemic AgentsMaleMiceMiddle AgedPioglitazoneRiluzoleSurvival RateAnticonvulsantsHypoglycemic AgentsPioglitazoneRiluzoleThiazolidinediones

Identifiers

PMID22715372
PMCPMC3371007
OpenAlexW1968427639

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.