Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis

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