Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: AZILECT® 1 mg Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Rasagiline Mesilate
CAS Number: 161735-79-1
Other descriptive name: RASAGILINE MESILATE
Concentration unit: mg mill
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria 2. 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 3. Vital capacity more than 50% of normal (slow vital capacity; best of three measurements) 4. Age: = 18 years 5. Continuously treated with 100 mg riluzole for at least four weeks 6. Capable of thoroughly understanding all information given and giving full informed consent according to GCP 7. 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 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Previous participation in another clinical study within the preceding 12 weeks 2. Tracheostomy or assisted ventilation of any type during the preceding three months 3. Gastrostomy 4. Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS 5. Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment 6. Patients on sympathomimetic agents, including pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine 7. Patients on analgesics with serotoninergic properties such as meperidine, tramadol, methadone and propoxyphen 8. Patients on serotonin reuptake inhibitors (SSRIs),including fluoxetine or fluvoxamine 9. Patients on dextromethorphan, St. John’s wort, cyclobenzaprine or other MAO inhibitors (selective or non-selective) 10. Patients taking antidepressants 11. Confirmed hepatic insufficiency or abnormal liver function (ASAT and/or ALAT greater than 3 times the upper limit of the normal range) 12. Renal insufficiency (serum creatinine more than 2.26 mg/dL) 13. Evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms 14. Known hypersensitivity to any component of the study drug 15. 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 16. Female with childbearing potential, if no adequate contraceptive measures are used 17. Pregnancy or breast-feeding females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of rasagiline as add-on therapy to standard therapy with riluzole in patients with ALS compared to placebo in terms of survival (mortality exclusively defined as death).;Secondary Objective: 1. The change of total score of ALS Functional Rating Scale – Revised (ALSFRS-R) 2. The change in individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life) 3. The change of the slow vital capacity (sVC) ;Primary end point(s): Primary efficacy endpoint: survival time (time to death).;Timepoint(s) of evaluation of this end point: at each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change of total score of ALS Functional Rating Scale - Revised (ALSFRS-R) 2. Change in individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life) 3. Change of the slow vital capacity (sVC) ;Timepoint(s) of evaluation of this end point: at each visit | — |
Countries
Germany
Contacts
Public ContactProf. Dr. A.C. Ludolph
Universitätsklinikum Ulm
Outcome results
None listed