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Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)

A Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of Randomization

NCT00403104•Ono Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared with placebo group.

Eligibility

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable or clinically definite ALS (according to WNF EL Escorial diagnostic criteria, revised according to the Airlie House Conference 1998)
•2. Onset of muscle weakness within 14 months randomization
•3. Concomitant standard Riluzole therapy (50mg twice daily)

Exclusion Criteria

•1. Presence of a tracheotomy, mechanical ventilation or non-invasive ventilation
•2. Requirement for prescription drugs used for potential neuroprotective benefit -

Locations (26)

L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien

Vienna, Austria

UCL Saint-Luc

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Hopital Roger Salengro - Clinique Neurologique, Neurologie A

Lille, France

Hopital Duruytren

Limoges, France

Hopital de la Timone

Marseille, France

Hopital de Chauliac

Montpellier, France

Hopital l-Archet 1

Nice, France

Hopital LaPitie Salpetriere

Paris, France

Charite Campus Virchow, ALS Ambulanz

Berlin, Germany

Key Dates

Start Date

November 1, 2006

Primary Completion Date

December 1, 2008

Completion Date

December 1, 2008

Last Updated

June 13, 2012

Enrollment

420

ACTUAL participants

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

ONO-2506PO

DRUG

ONO-2506PO

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)

Inclusion Criteria

Exclusion Criteria

Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease.

Integrating Metabolism, Connectivity, and Mesoscale Imaging at Ultra-high Field to Decipher Mechanisms of Resilience and Neurodegeneration in Neurological Diseases and Healthy Aging

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A Study to Evaluate the Tolerability, Safety and Efficacy of VGN-R13 in Patients with ALS

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