Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Albert Christian Ludolph, Prof., University of Ulm
ClinicalTrials.gov Identifier:
NCT01879241
First received: June 12, 2013
Last updated: December 1, 2014
Last verified: December 2014
  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: July 2016
Estimated Primary Completion Date: March 2016 (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

Locations
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
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: December 1, 2014
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
Motor Neuron Disease
Sclerosis
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies
Rasagiline
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 29, 2015