Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis
Information source: University of Ulm
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amyotrophic Lateral Sclerosis
Intervention: pioglitazone (Drug); placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Ulm Official(s) and/or principal investigator(s):
Albert C Ludolph, MD, Prof., Principal Investigator, Affiliation: Department of Neurology, University of Ulm
Overall contact:
Albert C Ludolph, MD, Prof., Phone: +49-731-177-, Ext: 1200, Email: albert.ludolph@rku.de
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.
Clinical Details
Official title: Efficacy, Safety and Tolerability Study of 45 mg Pioglitazone in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole)
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Survival in patients with ALS treated with pioglitazone compared to placebo
Secondary outcome: Incidence of tracheotomy or non-invasive ventilation
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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:
- 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
Locations and Contacts
Albert C Ludolph, MD, Prof., Phone: +49-731-177-, Ext: 1200, Email: albert.ludolph@rku.de
Department of Neurology, Humboldt University, Berlin 13353, Germany; Not yet recruiting
Thomas Meyer, MD, Prof., Phone: +49-30-450560-, Ext: 032, Email: thomas.meyer@charite.de
Thomas Meyer, MD, Prof., Principal Investigator
Department of Neurology, University of Milano, Milano 20149, Italy; Not yet recruiting
Vincenco Silani, MD, Prof., Phone: +39-02-61911-, Ext: 2937, Email: Vincenco@Silani.com
Vincenco Silani, MD, Prof., Principal Investigator
Department of Neurology, University of Ulm, Ulm, Baden-Württemberg 89081, Germany; Recruiting
Albert C Ludolph, MD, Prof., Phone: +49-731-177-, Ext: 1200, Email: albert.ludolph@rku.de
Albert C Ludolph, MD, Prof., Principal Investigator
Department of Neurology, University of Erlangen, Erlangen, Bayern 91054, Germany; Not yet recruiting
Dieter Heuss, MD, Prof., Phone: +49-9131-853-, Ext: 4563, Email: dieter.heuss@neuro.med.uni-erlangen.de
Dieter Heuss, MD, Prof., Principal Investigator
Department of Neurology, University of Wuerzburg, Wuerzburg, Bayern 91054, Germany; Not yet recruiting
Klaus V Toyka, MD, Prof., Phone: +49-931-201-, Ext: 5750, Email: k.toyka@mail.uni-wuerzburg.de
Klaus V Toyka, MD, Prof., Principal Investigator
Department of Neurology, Medical School Hannover, Hannover, Niedersachsen 30625, Germany; Not yet recruiting
Reinhard Dengler, MD, Prof., Phone: +49-511-532-, Ext: 2391, Email: Dengler.Reinhard@mh-hannover.de
Reinhard Dengler, MD, Prof., Principal Investigator
Neurologische Universitätsklinik Bergmannsheil, Bochum, Nordrhein-Westfalen 44789, Germany; Active, not recruiting
Department of Neurology, University of Halle-Wittenberg, Halle/Saale, Sachsen-Anhalt 06097, Germany; Not yet recruiting
Stephan Zierz, MD, Prof., Phone: +49-345-557-, Ext: 2858
Stephan Zierz, MD, Prof., Principal Investigator
Additional Information
Related publications: Schütz B, Reimann J, Dumitrescu-Ozimek L, Kappes-Horn K, Landreth GE, Schürmann 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. 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.
Starting date: May 2008
Ending date: July 2010
Last updated: June 3, 2008
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