Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) - An AMG Trial With a Market Authorized Substance

https://clinicalt...CT01879241&rank=1

Minimum Age:

18 Years

Maximum Age:

N/A

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