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

Phase 2

Completed

• Conditions: Amyotrophic Lateral Sclerosis (ALS)
• Interventions: Drug: ONO-2506PO

• Registration Number: NCT00403104
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-22
• Study First Submitted QC: 2006-11-22
• Study First Posted: 2006-11-23
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	ONO-2506PO	Placebo in the presence of Riluzole
E	ONO-2506PO	ONO-2506PO in the presence of Riluzole

Primary Outcome Measures

Name	Time	Method
Rate of decline of respiratory function determined as SVC over the 12 month treatment period	12 months

Secondary Outcome Measures

Name	Time	Method
Survival	12, 18 months
Functional Assessment (ALSFRS-R)	12, 18 months
Muscle Strength (MRC muscle score)	12, 18 months
Quality of Life	12, 18 months

Trial Locations

Locations (26)

L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien; 🇦🇹 Wien, Austria

UCL Saint-Luc; 🇧🇪 Brussels, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Hopital Roger Salengro - Clinique Neurologique, Neurologie A; 🇫🇷 Lille Cedex, France

Hopital Duruytren; 🇫🇷 Limoges Cedex, France

Hopital de la Timone; 🇫🇷 Marseille, France

Hopital de Chauliac; 🇫🇷 Montpellier cedex 5, France

Hopital l-Archet 1; 🇫🇷 Nice cedex 3, France

Hopital LaPitie Salpetriere; 🇫🇷 Paris, France

Charite Campus Virchow, ALS Ambulanz; 🇩🇪 Berlin, Germany

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