Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis

University of Ulm

Status and phase

Completed

Phase 2

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Drug: Rasagiline

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01879241

RAS-ALS

2011-004482-32 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the trial is to investigate the survival time (the time from randomization until death or end of the trial) compared between control group and experimental group.

This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind trial comparing placebo with 1 mg/d rasagiline as add-on therapy to 100 mg riluzole in amyotrophic lateral sclerosis (ALS) in 250 enrolled patients. For entry, the El Escorial Criteria for the diagnosis of ALS will be used. The patients have to be stable on riluzole at least 4 weeks prior to randomization.

Enrollment

252 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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