MedTrace Logo

Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis

NCT01879241 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2016-10-25

No results posted yet for this study

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

Interventions

DRUG

Rasagiline

DRUG

Placebo

a sugar pill manufactured to mimic Rasagiline 1 mg tablet

Sponsors & Collaborators

  • University of Ulm

    lead OTHER

Principal Investigators

  • Albert C. Ludolph, MD, Prof. · Department of Neurology, University of Ulm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-04-30
Completion
2016-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01879241 on ClinicalTrials.gov