Study of Rasagiline 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 (inclusive). Disease onset defined as date of first muscle weakness, excluding fasciculations and cramps
• Vital capacity more than 50% of normal (slow vital capacity; best of three measurements)
• Age: ≥ 18 years
• Continuously treated with 100 mg riluzole for at least four weeks
• 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 vasectomized partner

Exclusion criteria

• Previous participation in another clinical study within the preceding 12 weeks
• Tracheostomy 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
• Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine.
• Patients on analgesics with serotoninergic properties such as meperidine, tramadol, methadone and propoxyphene.
• Patients on serotonin reuptake inhibitors (SSRIs). This includes fluoxetine or fluvoxamine.
• Patients on dextromethorphan, St. John's wort, cyclobenzaprine or other MAO inhibitors (selective or non-selective)
• Patients taking Antidepressants
• Confirmed hepatic insufficiency or abnormal liver function (ASAT and/or ALAT greater than 3 times the upper limit of the normal range)
• 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 drug
• Liable to be not cooperative or comply with the trial requirements (as assessed by the investigator), or unable to be reached in the case of emergency
• Female with childbearing potential, if no adequate contraceptive measures are used
• Pregnancy or breast-feeding females