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Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT01879241
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : October 25, 2016
Information provided by (Responsible Party):
Albert Christian Ludolph, Prof., University of Ulm

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Rasagiline Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: Rasagiline


1 mg/day; 18 months

Drug: Rasagiline
Placebo Comparator: Placebo
once daily, 18 months
Drug: Placebo
a sugar pill manufactured to mimic Rasagiline 1 mg tablet

Primary Outcome Measures :
  1. Survival in ALS-Patients with Rasagiline compared to placebo [ Time Frame: 18 Months ]

Secondary Outcome Measures :
  1. Change of total score of ALS Functional Rating Scale - Revised (ALSFRS-R) [ Time Frame: 18 Months ]
  2. Change of individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life [ Time Frame: 18 Months ]
  3. Change of slow vital capacity [ Time Frame: 18 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879241

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Department of Neurology, University of Ulm
Ulm, Baden-Württemberg, Germany, 89081
Department of Neurology, Technische Universität München
Muenchen, Bayern, Germany, D-81675
Department of Neurology, Universty of Regensburg
Regensburg, Bayern, Germany, D-93053
Department of Neurology, University of Wuerzburg
Wuerzburg, Bayern, Germany, 91054
Department of Neurology, Deutsche Klinik für Diagnostik
Wiesbaden, Hessen, Germany, D-65191
Department of Neurology, University of Rostock
Rostock, Mecklenburg-Vorpommern, Germany, D-18147
Department of Neurology, University of Goettingen
Goettingen, Niedersachsen, Germany, D-37073
Department of Neurology, Medical School Hannover
Hannover, Niedersachsen, Germany, 30625
Neurologische Universitätsklinik Bergmannsheil
Bochum, Nordrhein-Westfalen, Germany, 44789
Department of Neurology, Universty of Muenster
Muenster, Nordrhein-Westfalen, Germany, D-48149
Department of Neurology, Universty of Bonn
Bonn, Nordrhrein-Westfalen, Germany, D-53105
Department of Neurology, University of Halle-Wittenberg
Halle/Saale, Sachsen-Anhalt, Germany, 06097
Department of Neurology, TU Dresden
Dresden, Sachsen, Germany, D-01307
Department of Neurology, University of Jena
Jena, Thueringen, Germany, D-07747
Department of Neurology, Humboldt University
Berlin, Germany, 13353
Sponsors and Collaborators
University of Ulm
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Principal Investigator: Albert C. Ludolph, MD, Prof. Department of Neurology, University of Ulm
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Albert Christian Ludolph, Prof., MD, Prof., University of Ulm
ClinicalTrials.gov Identifier: NCT01879241    
Other Study ID Numbers: RAS-ALS
2011-004482-32 ( EudraCT Number )
First Posted: June 17, 2013    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Keywords provided by Albert Christian Ludolph, Prof., University of Ulm:
amyotrophic lateral sclerosis
survival time
ALS functioning Rating Scale
quality of life
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs