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

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis (ALS)
• Intervention / Treatment: Drug: ONO-2506PO; Drug: ONO-2506PO

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1100
    • L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien
• Belgium
  • Brussels, Belgium
    • UCL Saint-Luc
  • Leuven, Belgium, 3000
    • UZ Leuven
• France
  • Lille Cedex, France, 59037
    • Hopital Roger Salengro - Clinique Neurologique, Neurologie A
  • Limoges Cedex, France, 87042
    • Hopital Duruytren
  • Marseille, France, 13005
    • Hopital De La Timone
  • Montpellier cedex 5, France, 34295
    • Hôpital de Chauliac
  • Nice cedex 3, France, 06202
    • Hopital l-Archet 1
  • Paris, France, 75013
    • Hopital LaPitie Salpetriere
• Germany
  • Berlin, Germany, 13353
    • Charite Campus Virchow, ALS Ambulanz
  • Bochum, Germany, 44789
    • Neurologische Universitätsklinik Bergmannsheil
  • Erlangen, Germany, 91054
    • Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik
  • Halle, Germany, 06120
    • Martin-Luther-Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie
  • Hannover, Germany, 30623
    • Medizinische Hochschule Hannover, Neurologische Klinik
  • Munchen, Germany
    • Interdisziplinares Zentrum fur Palliativmedizin
  • Ulm, Germany, 89081
    • Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm
  • Wiesbaden, Germany, 65191
    • Deutsche Klinik fur Diagnostik, Fachbereich Neurologie
• Italy
  • Milano, Italy, 20149
    • Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano
  • Pavia, Italy, 27100
    • Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS
  • Torino, Italy, 10126
    • Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette
• Netherlands
  • Amsterdam, Netherlands
    • Academic Medical Centre (AMC) Amsterdam - Dept of Neurology
  • Utrecht, Netherlands
    • University Medial Center Utrecht
• Switzerland
  • St. Gallen, Switzerland, 9007
    • Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic
• United Kingdom
  • London, United Kingdom
    • Academic Neuroscience Centre
  • Preston, United Kingdom, PR29HT
    • Royal Preston Hospital
  • Sheffield, United Kingdom
    • University of Sheffield - Academic Neurology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E; ONO-2506PO in the presence of Riluzole	Drug: ONO-2506PO; 1200 mg QD / 18 months; Drug: ONO-2506PO; 0 mg QD / 18 months
Placebo Comparator: P; Placebo in the presence of Riluzole	Drug: ONO-2506PO; 1200 mg QD / 18 months; Drug: ONO-2506PO; 0 mg QD / 18 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of decline of respiratory function determined as SVC over the 12 month treatment period	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Tomohiro Kuwayama, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: November 22, 2006
• First Submitted That Met QC Criteria: November 22, 2006
• First Posted (Estimate): November 23, 2006

Study Record Updates

• Last Update Posted (Estimate): June 13, 2012
• Last Update Submitted That Met QC Criteria: June 12, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Amyotrophic Lateral Sclerosis; ALS; ONO-2506PO
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: ONO-2506POE014