Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT00690118
Eligibility 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
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00690118
Study Brief:
Protocol Section:
NCT00690118