Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients with Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole)

Phase 1

• Conditions: Amyotrophic Lateral Sclerosis (ALS); MedDRA version: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-004482-32-DE
• Lead Sponsor: niversitätsklinikum Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-21
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>2. The change in individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life)<br>3. The change of the slow vital capacity (sVC)<br>;Primary end point(s): Primary efficacy endpoint: survival time (time to death).;Timepoint(s) of evaluation of this end point: at each visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change of total score of ALS Functional Rating Scale - Revised (ALSFRS-R)<br>2. Change in individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life)<br>3. Change of the slow vital capacity (sVC)<br>;Timepoint(s) of evaluation of this end point: at each visit