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Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis | Clinical Trials | Clareo Health

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Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis

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

NCT01879241•University of Ulm

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+7 more criteria

Locations (15)

Department of Neurology, University of Ulm

Ulm, Baden-Wurttemberg, Germany

Department of Neurology, Technische Universität München

Munich, Bavaria, Germany

Department of Neurology, Universty of Regensburg

Regensburg, Bavaria, Germany

Department of Neurology, University of Wuerzburg

Würzburg, Bavaria, Germany

Department of Neurology, Deutsche Klinik für Diagnostik

Wiesbaden, Hesse, Germany

Department of Neurology, University of Goettingen

Göttingen, Lower Saxony, Germany

Department of Neurology, Medical School Hannover

Hanover, Lower Saxony, Germany

Department of Neurology, University of Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Department of Neurology, Universty of Bonn

Bonn, Nordrhrein-Westfalen, Germany

Neurologische Universitätsklinik Bergmannsheil

Bochum, North Rhine-Westphalia, Germany

Key Dates

Start Date

June 1, 2013

Primary Completion Date

April 1, 2016

Completion Date

August 1, 2016

Last Updated

October 25, 2016

Enrollment

252

ACTUAL participants

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Rasagiline

DRUG

Placebo

DRUG

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

NCT07322003

Amyotrophic Lateral Sclerosis

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RECRUITING

Intermuscular Coherence as a Biomarker for ALS

NCT05104710

Amyotrophic Lateral Sclerosis

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RECRUITINGNA

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

NCT07357428

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 25, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis

Inclusion Criteria

Exclusion Criteria

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Intermuscular Coherence as a Biomarker for ALS

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

UPenn Observational Research Repository on Neurodegenerative Disease

Control Cohort CTRL COH

Identifying Biomarkers in ALS Patients Using Neuronal Derived Extracellular Vesicles