Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Drug: placebo
- Registration Number
- NCT00690118
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 219
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 placebo - 1 pioglitazone -
- Primary Outcome Measures
Name Time Method Survival in patients with ALS treated with pioglitazone compared to placebo 18 months
- Secondary Outcome Measures
Name Time Method Incidence of tracheotomy or non-invasive ventilation 18 month
Trial Locations
- Locations (15)
Department of Neurology and Center for Palliative Medicine, University of Munich
🇩🇪Muenchen, Bayern, Germany
Department of Neurology, University of Goettingen
🇩🇪Goettingen, Niedersachsen, Germany
Department of Neurology, University of Halle-Wittenberg
🇩🇪Halle/Saale, Sachsen-Anhalt, Germany
Department of Neurology, University of Rostock
🇩🇪Rostock, Mecklenburg-Vorpommern, Germany
Department of Neurology, Universty of Regensburg
🇩🇪Regensburg, Bayern, Germany
Department of Neurology, University of Wuerzburg
🇩🇪Wuerzburg, Bayern, Germany
Neurologische Universitätsklinik Bergmannsheil
🇩🇪Bochum, Nordrhein-Westfalen, Germany
Department of Neurology, Universty of Bonn
🇩🇪Bonn, Nordrhrein-Westfalen, Germany
Department of Neurology, TU Dresden
🇩🇪Dresden, Sachsen, Germany
Department of Neurology, Deutsche Klinik für Diagnostik
🇩🇪Wiesbaden, Hessen, Germany
Department of Neurology, Medical School Hannover
🇩🇪Hannover, Niedersachsen, Germany
Department of Neurology, Humboldt University
🇩🇪Berlin, Germany
Department of Neurology, Universty of Muenster
🇩🇪Muenster, Nordrhein-Westfalen, Germany
Department of Neurology, University of Jena
🇩🇪Jena, Thueringen, Germany
Department of Neurology, University of Ulm
🇩🇪Ulm, Baden-Württemberg, Germany