Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis
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ClinicalTrials.gov 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
|
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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 |
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
|
- Survival in patients with ALS treated with pioglitazone compared to placebo [ Time Frame: 18 months ]
- Incidence of tracheotomy or non-invasive ventilation [ Time Frame: 18 month ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

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 ClinicalTrials.gov identifier (NCT number): NCT00690118
Germany | |
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 |
Principal Investigator: | Albert C Ludolph, MD, Prof. | Department of Neurology, University of Ulm |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Albert Christian Ludolph, Prof., Coordinating Investigator, University of Ulm |
ClinicalTrials.gov Identifier: | NCT00690118 History of Changes |
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 survival |
Additional relevant MeSH terms:
Sclerosis Amyotrophic Lateral Sclerosis Motor Neuron Disease Pathologic Processes Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases |
Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs |