Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879241
• Other study ID #: RAS-ALS
• Secondary ID: 2011-004482-32
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2013
• Last updated: October 24, 2016
• Start date: June 2013
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: August 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• Rasagiline

• Placebo
a sugar pill manufactured to mimic Rasagiline 1 mg tablet

Locations

Country	Name	City	State
Germany	Department of Neurology, Humboldt University	Berlin
Germany	Neurologische Universitätsklinik Bergmannsheil	Bochum	Nordrhein-Westfalen
Germany	Department of Neurology, Universty of Bonn	Bonn	Nordrhrein-Westfalen
Germany	Department of Neurology, TU Dresden	Dresden	Sachsen
Germany	Department of Neurology, University of Goettingen	Goettingen	Niedersachsen
Germany	Department of Neurology, University of Halle-Wittenberg	Halle/Saale	Sachsen-Anhalt
Germany	Department of Neurology, Medical School Hannover	Hannover	Niedersachsen
Germany	Department of Neurology, University of Jena	Jena	Thueringen
Germany	Department of Neurology, Technische Universität München	Muenchen	Bayern
Germany	Department of Neurology, Universty of Muenster	Muenster	Nordrhein-Westfalen
Germany	Department of Neurology, Universty of Regensburg	Regensburg	Bayern
Germany	Department of Neurology, University of Rostock	Rostock	Mecklenburg-Vorpommern
Germany	Department of Neurology, University of Ulm	Ulm	Baden-Württemberg
Germany	Department of Neurology, Deutsche Klinik für Diagnostik	Wiesbaden	Hessen
Germany	Department of Neurology, University of Wuerzburg	Wuerzburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival in ALS-Patients with Rasagiline compared to placebo		18 Months	Yes
Secondary	Change of total score of ALS Functional Rating Scale - Revised (ALSFRS-R)		18 Months	No
Secondary	Change of individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life		18 Months	No
Secondary	Change of slow vital capacity		18 Months	No