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
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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 |
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
Rasagiline 1 mg/day; 18 months |
Drug: Rasagiline |
Placebo Comparator: Placebo
once daily, 18 months
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Drug: Placebo
a sugar pill manufactured to mimic Rasagiline 1 mg tablet |
- Survival in ALS-Patients with Rasagiline compared to placebo [ Time Frame: 18 Months ]
- Change of total score of ALS Functional Rating Scale - Revised (ALSFRS-R) [ Time Frame: 18 Months ]
- Change of individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life [ Time Frame: 18 Months ]
- Change of slow vital capacity [ Time Frame: 18 Months ]

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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

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
Germany | |
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 |
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):
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 |
amyotrophic lateral sclerosis survival time ALS functioning Rating Scale quality of life survival |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies |
Proteostasis Deficiencies Metabolic Diseases Rasagiline Monoamine Oxidase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Neuroprotective Agents Protective Agents Physiological Effects of Drugs |