Male or female adult patients with amyotrophic lateral sclerosis (ALS) accoring to the El Escorial Criteria for the diognosis of ALS and treated for at least 3 month with 100 mg riluzole (standard therapy). MedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral sclerosis
Conditions
Interventions
Trade Name: Actos 15 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the
Sponsors
University Hospital of Ulm
Eligibility
Sex/Gender
All
Inclusion 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 (inclusive). Disease onset defined as date of first muscle weakness, excluding fasciculation and cramps •Best-sitting SVC between 50 % and 95 % of predicted normal •Continuously treated with 100 mg riluzole daily, for at least 3 months •Capable of thoroughly understanding all information given and giving full informed consent according to GCP •Women of childbearing age must be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test. Acceptable methods of birth control with a low failure rate i.e. less than 1% per year) when used consistently and correct are such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), or double-barrier methods (condom or diaphragm with spermicidal agent or IUD), sexual abstinence or vasectomised partner •Onset of progressive weakness within 36 months prior to study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Previous participation in another clinical study within the preceding 12 weeks •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 > 1.5 upper limit of normal) •Renal insufficiency (serum creatinine > 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of pioglitazone (45 mg/day) as add-on therapy to standard therapy with riluzole in patients with amyotrophic lateral sclerosis compared to placebo in terms of survival (mortality defined exclusively as death).;Secondary Objective: Secondary efficacy variables will include incidence of tracheotomy or non-invasive ventilation (NIV), ALS Functioning Rating Scale (ALSFRS-R; the revised version including the respiratory parameters), and measurement of quality of life using the Euroqol EQ-5D. Clinical tolerability and safety will be assessed by findings of physical examination, adverse events incidence, and clinical laboratory values.;Primary end point(s): Efficacy of pioglitazone (45 mg/day) as add-on therapy to standard therapy with riluzole in patients with amyotrophic lateral sclerosis compared to placebo in terms of survival (mortality defined exclusively as death). The primary endpoint will be subjected to a confirmatory analysis. All secondary and safety parameters will be evaluated and reported descriptively. | — |
Countries
Germany
Outcome results
None listed