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

NCT00403104 | Completed Phase 2

• 1 other identifier: ONO-2506POE014
• Study Type: interventional
• Target: 420
• Locations: 8 countries
• Sites: 26

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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Keywords

ONO-2506PO; Amyotrophic Lateral Sclerosis; ALS

Outcome Measures

Primary Outcomes (1)

• Rate of decline of respiratory function determined as SVC over the 12 month treatment period

  12 months

Secondary Outcomes (4)

• 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

Study Arms (2)

E

EXPERIMENTAL

ONO-2506PO in the presence of Riluzole

Drug: ONO-2506PO

P

PLACEBO COMPARATOR

Placebo in the presence of Riluzole

Drug: ONO-2506PO

Interventions

ONO-2506PO DRUG

1200 mg QD / 18 months

E

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Onset of muscle weakness within 14 months randomization
• Concomitant standard Riluzole therapy (50mg twice daily)

You may not qualify if:

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

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (26)

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

Vienna, 1100, Austria

Location

UCL Saint-Luc

Brussels, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Hopital Roger Salengro - Clinique Neurologique, Neurologie A

Lille, 59037, France

Location

Hopital Duruytren

Limoges, 87042, France

Location

Hopital de la Timone

Marseille, 13005, France

Location

Hopital de Chauliac

Montpellier, 34295, France

Location

Hopital l-Archet 1

Nice, 06202, France

Location

Hopital LaPitie Salpetriere

Paris, 75013, France

Location

Charite Campus Virchow, ALS Ambulanz

Berlin, 13353, Germany

Location

Neurologische Universitatsklinik Bergmannsheil

Bochum, 44789, Germany

Location

Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik

Erlangen, 91054, Germany

Location

Martin-Luther-Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie

Halle, 06120, Germany

Location

Medizinische Hochschule Hannover, Neurologische Klinik

Hanover, 30623, Germany

Location

Interdisziplinares Zentrum fur Palliativmedizin

München, Germany

Location

Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm

Ulm, 89081, Germany

Location

Deutsche Klinik fur Diagnostik, Fachbereich Neurologie

Wiesbaden, 65191, Germany

Location

Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano

Milan, 20149, Italy

Location

Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS

Pavia, 27100, Italy

Location

Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette

Torino, 10126, Italy

Location

Academic Medical Centre (AMC) Amsterdam - Dept of Neurology

Amsterdam, Netherlands

Location

University Medial Center Utrecht

Utrecht, Netherlands

Location

Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic

Sankt Gallen, 9007, Switzerland

Location

Academic Neuroscience Centre

London, United Kingdom

Location

Royal Preston Hospital

Preston, PR29HT, United Kingdom

Location

University of Sheffield - Academic Neurology Unit

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Tomohiro Kuwayama

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2006
• First Posted: November 23, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 13, 2012

Record last verified: 2012-06

Locations

AU (1); FR (6); GB (3); IT (3); NL (2); DE (8); BE (2); CH (1)