Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Ulm
Sponsor:
Information provided by (Responsible Party):
Albert Christian Ludolph, Prof., University of Ulm
ClinicalTrials.gov Identifier:
NCT01879241
First received: June 12, 2013
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Amyotrophic Lateral Sclerosis
Drug: Rasagiline
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Survival in ALS-Patients with Rasagiline compared to placebo [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change of total score of ALS Functional Rating Scale - Revised (ALSFRS-R) [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
  • Change of individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
  • Change of slow vital capacity [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rasagiline

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879241

Contacts
Contact: Albert C Ludolph, MD, Prof. +49-731-177 ext 1200 albert.ludolph@rku.de

Locations
Germany
Department of Neurology, University of Ulm Recruiting
Ulm, Baden-Württemberg, Germany, 89081
Contact: Albert C Ludolph, MD, Prof.    +49-731-177- ext 1200    albert.ludolph@rku.de   
Principal Investigator: Albert C Ludolph, MD, Prof.         
Department of Neurology, Technische Universität München Recruiting
Muenchen, Bayern, Germany, D-81675
Contact: Andrea Winkler, Prof. Dr.    +49 89 - 4140 ext 4630    drawinkler@yahoo.com.au   
Principal Investigator: Andrea Winkler, Dr. Dr.         
Department of Neurology, Universty of Regensburg Recruiting
Regensburg, Bayern, Germany, D-93053
Contact: Wilhelm Schulte-Mattler, Prof. Dr.    +49-941-941 ext 0    wilhelm.schulte-mattler@klinik.uni-regensburg.de   
Principal Investigator: Wilhelm Schulte-Mattler, Prof. Dr.         
Department of Neurology, University of Wuerzburg Recruiting
Wuerzburg, Bayern, Germany, 91054
Contact: Klebe Stephan, PD Dr.    +49-931-201- ext 5750    Klebe_S@klinik.uni-wuerzburg.de   
Principal Investigator: Stephan Klebe, Dr.         
Department of Neurology, Deutsche Klinik für Diagnostik Recruiting
Wiesbaden, Hessen, Germany, D-65191
Contact: Bertold Schrank, Dr.    +49-611-577 ext 431    schrank.neuro@dkd-wiesbaden.de   
Principal Investigator: Bertold Schrank, Dr.         
Department of Neurology, University of Rostock Recruiting
Rostock, Mecklenburg-Vorpommern, Germany, D-18147
Contact: Johannes Prudlo, PD Dr.    +49-381-494 ext 4742    johannes.prudlo@med.uni-rostock.de   
Sub-Investigator: Johannes Prudlo, PD Dr.         
Department of Neurology, University of Goettingen Recruiting
Goettingen, Niedersachsen, Germany, D-37073
Contact: Bettina Göricke, Dr.    +49-551-39 ext 12581    jochen.weishaupt@medizin.uni.goettingen.de   
Principal Investigator: Bettina Göricke, Dr.         
Department of Neurology, Medical School Hannover Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Susanne Petri, Prof. Dr.    +49-511-532- ext 3740    Petri.Susanne@mh-hannover.de   
Principal Investigator: Susanne Petri, Prof. Dr.         
Neurologische Universitätsklinik Bergmannsheil Recruiting
Bochum, Nordrhein-Westfalen, Germany, 44789
Contact: Torsten Grehl, MD    +49-234-302- ext 6812    Torsten.Grehl@rub.de   
Principal Investigator: Torsten Grehl, MD         
Department of Neurology, Universty of Muenster Recruiting
Muenster, Nordrhein-Westfalen, Germany, D-48149
Contact: Matthias Böntert, Dr.    +49-251-83 ext 47955    young@uni-muenster.de   
Principal Investigator: Matthias Böntert, Dr.         
Department of Neurology, Universty of Bonn Recruiting
Bonn, Nordrhrein-Westfalen, Germany, D-53105
Contact: Michael T. Heneka, Prof. Dr.    +49-228-287 ext 13092    michael.heneka@ukb.uni-bonn.de   
Principal Investigator: Michael T. Heneka, Prof. Dr.         
Department of Neurology, University of Halle-Wittenberg Recruiting
Halle/Saale, Sachsen-Anhalt, Germany, 06097
Contact: Frank Hanisch, Dr.    +49-345-557- ext 3340    frank.hanisch@medizin.uni-halle.de   
Principal Investigator: Frank Hanisch, Dr.         
Department of Neurology, TU Dresden Recruiting
Dresden, Sachsen, Germany, D-01307
Contact: Andreas Hermann, Dr.    +49-351-458 ext 2532    alexander.storch@neuro.med.tu-dresden.de   
Principal Investigator: Andreas Hermann, Dr.         
Department of Neurology, University of Jena Recruiting
Jena, Thueringen, Germany, D-07747
Contact: Julian Grosskreutz, PD Dr.    +49-3641-932 ext 3426    julian.grosskreutz@med.uni-jena.de   
Principal Investigator: Julian Grosskreutz, PD Dr.         
Department of Neurology, Humboldt University Recruiting
Berlin, Germany, 13353
Contact: Thomas Meyer, MD, Prof.    +49-30-450560- ext 032    thomas.meyer@charite.de   
Principal Investigator: Thomas Meyer, MD, Prof.         
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Albert C. Ludolph, MD, Prof. Department of Neurology, University of Ulm
  More Information

Publications:
Responsible Party: Albert Christian Ludolph, Prof., MD, Prof., University of Ulm
ClinicalTrials.gov Identifier: NCT01879241     History of Changes
Other Study ID Numbers: RAS-ALS, 2011-004482-32
Study First Received: June 12, 2013
Last Updated: August 20, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Ulm:
amyotrophic lateral sclerosis
survival time
ALS functioning Rating Scale
quality of life
survival

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014