Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis

NCT ID: NCT01879241

Last Updated: 2016-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-08-31

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rasagiline

Rasagiline

1 mg/day; 18 months

Group Type: EXPERIMENTAL

Rasagiline

Intervention Type: DRUG

Placebo

once daily, 18 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

a sugar pill manufactured to mimic Rasagiline 1 mg tablet

Interventions

Rasagiline

Intervention Type: DRUG

Placebo

a sugar pill manufactured to mimic Rasagiline 1 mg tablet

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Albert Christian Ludolph, Prof.

MD, Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Albert C. Ludolph, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University of Ulm

Locations

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

Department of Neurology, Universty of Muenster

Münster, North Rhine-Westphalia, Germany

Department of Neurology, TU Dresden

Dresden, Saxony, Germany

Department of Neurology, University of Halle-Wittenberg

Halle, Saxony-Anhalt, Germany

Department of Neurology, University of Jena

Jena, Thuringia, Germany

Department of Neurology, Humboldt University

Berlin, , Germany

Countries

Germany

References

Waibel S, Reuter A, Malessa S, Blaugrund E, Ludolph AC. Rasagiline alone and in combination with riluzole prolongs survival in an ALS mouse model. J Neurol. 2004 Sep;251(9):1080-4. doi: 10.1007/s00415-004-0481-5.

Reference Type: BACKGROUND

PMID: 15372249 (View on PubMed)

Ludolph AC, Schuster J, Dorst J, Dupuis L, Dreyhaupt J, Weishaupt JH, Kassubek J, Weiland U, Petri S, Meyer T, Grosskreutz J, Schrank B, Boentert M, Emmer A, Hermann A, Zeller D, Prudlo J, Winkler AS, Grehl T, Heneka MT, Wollebaek Johannesen S, Goricke B; RAS-ALS Study Group. Safety and efficacy of rasagiline as an add-on therapy to riluzole in patients with amyotrophic lateral sclerosis: a randomised, double-blind, parallel-group, placebo-controlled, phase 2 trial. Lancet Neurol. 2018 Aug;17(8):681-688. doi: 10.1016/S1474-4422(18)30176-5. Epub 2018 Jun 19.

Reference Type: DERIVED

PMID: 29934198 (View on PubMed)

Other Identifiers

2011-004482-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RAS-ALS

Identifier Type: -

Identifier Source: org_study_id