Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis

Sponsor

University of Ulm (Other)

Overall Status

Completed

CT.gov ID

NCT01879241

Collaborator

(none)

252

Enrollment

Locations

Arms

Duration (Months)

16.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis	Drug: Rasagiline Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

252 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Survival in ALS-Patients with Rasagiline compared to placebo [18 Months]

Secondary Outcome Measures

Change of total score of ALS Functional Rating Scale - Revised (ALSFRS-R) [18 Months]
Change of individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life [18 Months]
Change of slow vital capacity [18 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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
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

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology, University of Ulm	Ulm	Baden-Württemberg	Germany	89081
2	Department of Neurology, Technische Universität München	Muenchen	Bayern	Germany	D-81675
3	Department of Neurology, Universty of Regensburg	Regensburg	Bayern	Germany	D-93053
4	Department of Neurology, University of Wuerzburg	Wuerzburg	Bayern	Germany	91054
5	Department of Neurology, Deutsche Klinik für Diagnostik	Wiesbaden	Hessen	Germany	D-65191
6	Department of Neurology, University of Rostock	Rostock	Mecklenburg-Vorpommern	Germany	D-18147
7	Department of Neurology, University of Goettingen	Goettingen	Niedersachsen	Germany	D-37073
8	Department of Neurology, Medical School Hannover	Hannover	Niedersachsen	Germany	30625
9	Neurologische Universitätsklinik Bergmannsheil	Bochum	Nordrhein-Westfalen	Germany	44789
10	Department of Neurology, Universty of Muenster	Muenster	Nordrhein-Westfalen	Germany	D-48149
11	Department of Neurology, Universty of Bonn	Bonn	Nordrhrein-Westfalen	Germany	D-53105
12	Department of Neurology, University of Halle-Wittenberg	Halle/Saale	Sachsen-Anhalt	Germany	06097
13	Department of Neurology, TU Dresden	Dresden	Sachsen	Germany	D-01307
14	Department of Neurology, University of Jena	Jena	Thueringen	Germany	D-07747
15	Department of Neurology, Humboldt University	Berlin		Germany	13353