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Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00690118
Recruitment Status : Terminated (The interim analysis showed no tendency in favour of the verum group. Therefore it was decided to stop the study prematurely.)
First Posted : June 4, 2008
Last Update Posted : May 29, 2015
Information provided by (Responsible Party):
Albert Christian Ludolph, Prof., University of Ulm

Brief 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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: pioglitazone Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Tolerability Study of 45 mg Pioglitazone in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole)
Study Start Date : May 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Active Comparator: 1 Drug: pioglitazone
45 mg/day, 18 months
Other Name: Actos

Placebo Comparator: 2 Drug: placebo
once daily, 18 months

Primary Outcome Measures :
  1. Survival in patients with ALS treated with pioglitazone compared to placebo [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Incidence of tracheotomy or non-invasive ventilation [ Time Frame: 18 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00690118

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Albert Christian Ludolph, Prof., Coordinating Investigator, University of Ulm Identifier: NCT00690118    
Other Study ID Numbers: GERP ALS
EUDRACT NUMBER 2006-005410-13
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015
Keywords provided by Albert Christian Ludolph, Prof., University of Ulm:
amyotrophic lateral sclerosis
survival time
ALS functioning Rating Scale
quality of life
non-invasive ventilation
clinical tolerability
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs