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TerminatedNCT00690118Updated May 29, 2015

Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis

A Phase 2 interventional study of pioglitazone and placebo in Amyotrophic Lateral Sclerosis, sponsored by University of Ulm. Terminated at 15 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-29.

Sponsored by University of Ulm · Phase 2, Interventional, and Treatment

Why this study was terminated
The interim analysis showed no tendency in favour of the verum group. Therefore it was decided to stop the study prematurely.
Phase
Phase 2
Study type
Interventional
Enrollment
219
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Primary objective:

Efficacy of pioglitazone (45 mg/day) as add-on therapy to standard therapy with riluzole in patients with ALS compared to placebo in terms of survival (mortality defined exclusively as death).

This is a prospective, multicentre, randomised, stratified, parallel-group, double-blind trial comparing placebo with 45 mg pioglitazone as add-on therapy to 100 mg riluzole in ALS in 220 enrolled patients. For entry, the El Escorial Criteria for diagnosis will be used. The duration of treatment will be 18 months. The primary endpoint will be subjected to a confirmatory analyses. Secondary variables will be incidence of tracheotomy or non-invasive ventilation, ALS Functional Rating Scale, Quality of life and safety variables.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis

Keywords

  • amyotrophic lateral sclerosis
  • survival time
  • ALS functioning Rating Scale
  • quality of life
  • non-invasive ventilation
  • clinical tolerability
  • survival
03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's enrollment of 219 is above the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

University of Ulm is the lead sponsor of 141 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria
  • disease duration more than 6 months and less than 3 years
  • best-sitting FVC between 50% and 95% of predicted normal
  • continuously treated with 100 mg riluzole daily, for at least one month
  • onset of progression weakness within 36 months prior to study
  • women of childbearing age be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test
  • capable of thoroughly understanding all information given and giving full informed consent according to GCP

Exclusion criteria

Exclusion Criteria:

  • previous participation in another clinical study within the preceding three months
  • tracheotomy or assisted ventilation of any type during the preceding three months
  • gastrostomy
  • any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
  • presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
  • confirmed hepatic insufficiency or abnormal liver function (ASAT and/or ALAT more than 1.5 upper limit of normal)
  • renal insufficiency (serum creatinine more than 2.26 mg/dl)
  • evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
  • known hypersensitivity to any component of the study drugs
  • likely to be not cooperative or comply with the trial requirements (as assessed by the investigator), or unable to be reached in the case of an emergency
  • other antidiabetics
  • heart failure or heart failure in the patients history (NYHA I to IV)
  • history of macular oedema
  • treatment with thiazolidinediones within 3 months prior to screening
  • known or suspected history of alcohol and/or drug abuse
  • treatment with gemfibrozil within 3 months prior to screening
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
219 participants (actual)

Study arms

  • Active comparator
    1

    Drug: pioglitazone

  • Placebo comparator
    2

    Drug: placebo

Interventions

  • Drugpioglitazone

    45 mg/day, 18 months

    Also known as: Actos

  • Drugplacebo

    once daily, 18 months

06

What researchers measure

Primary outcomes

  1. Survival in patients with ALS treated with pioglitazone compared to placebo

    Time frame: 18 months

Secondary outcomes

  1. Incidence of tracheotomy or non-invasive ventilation

    Time frame: 18 month

07

Study locations

15 sites
  • Department of Neurology, University of Ulm
    Ulm, Baden-Württemberg 89081, Germany
  • Department of Neurology and Center for Palliative Medicine, University of Munich
    Muenchen, Bayern D-81366, Germany
  • Department of Neurology, Universty of Regensburg
    Regensburg, Bayern D-93053, Germany
  • Department of Neurology, University of Wuerzburg
    Wuerzburg, Bayern 91054, Germany
  • Department of Neurology, Deutsche Klinik für Diagnostik
    Wiesbaden, Hessen D-65191, Germany
  • Department of Neurology, University of Rostock
    Rostock, Mecklenburg-Vorpommern D-18147, Germany
  • Department of Neurology, University of Goettingen
    Goettingen, Niedersachsen D-37073, Germany
  • Department of Neurology, Medical School Hannover
    Hannover, Niedersachsen 30625, Germany
  • Neurologische Universitätsklinik Bergmannsheil
    Bochum, Nordrhein-Westfalen 44789, Germany
  • Department of Neurology, Universty of Muenster
    Muenster, Nordrhein-Westfalen D-48149, Germany
  • Department of Neurology, Universty of Bonn
    Bonn, Nordrhrein-Westfalen D-53105, Germany
  • Department of Neurology, University of Halle-Wittenberg
    Halle/Saale, Sachsen-Anhalt 06097, Germany
  • Department of Neurology, TU Dresden
    Dresden, Sachsen D-01307, Germany
  • Department of Neurology, University of Jena
    Jena, Thueringen D-07747, Germany
  • Department of Neurology, Humboldt University
    Berlin, 13353, Germany
08

References and documents

Publications

  • Schutz B, Reimann J, Dumitrescu-Ozimek L, Kappes-Horn K, Landreth GE, Schurmann B, Zimmer A, Heneka MT. The oral antidiabetic pioglitazone protects from neurodegeneration and amyotrophic lateral sclerosis-like symptoms in superoxide dismutase-G93A transgenic mice. J Neurosci. 2005 Aug 24;25(34):7805-12. doi: 10.1523/JNEUROSCI.2038-05.2005. PubMed 16120782 ↗
  • Kiaei M, Kipiani K, Chen J, Calingasan NY, Beal MF. Peroxisome proliferator-activated receptor-gamma agonist extends survival in transgenic mouse model of amyotrophic lateral sclerosis. Exp Neurol. 2005 Feb;191(2):331-6. doi: 10.1016/j.expneurol.2004.10.007. PubMed 15649489 ↗
  • Dupuis L, Dengler R, Heneka MT, Meyer T, Zierz S, Kassubek J, Fischer W, Steiner F, Lindauer E, Otto M, Dreyhaupt J, Grehl T, Hermann A, Winkler AS, Bogdahn U, Benecke R, Schrank B, Wessig C, Grosskreutz J, Ludolph AC; GERP ALS Study Group. A randomized, double blind, placebo-controlled trial of pioglitazone in combination with riluzole in amyotrophic lateral sclerosis. PLoS One. 2012;7(6):e37885. doi: 10.1371/journal.pone.0037885. Epub 2012 Jun 8. PubMed 22715372 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00690118
Lead sponsor
University of Ulm
Responsible party
Albert Christian Ludolph, Prof. (Coordinating Investigator, University of Ulm) — Principal investigator
First posted
Jun 4, 2008
Start date
May 2008
Primary completion
Jun 2010
Completion
Jun 2010
Last update
May 29, 2015

Study contacts

Albert C Ludolph, MD, Prof.
principal investigator · Department of Neurology, University of Ulm

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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