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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00403104
First received: November 22, 2006
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Amyotrophic Lateral Sclerosis (ALS)
Drug: ONO-2506PO
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Rate of decline of respiratory function determined as SVC over the 12 month treatment period [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 12, 18 months ] [ Designated as safety issue: Yes ]
  • Functional Assessment (ALSFRS-R) [ Time Frame: 12, 18 months ] [ Designated as safety issue: No ]
  • Muscle Strength (MRC muscle score) [ Time Frame: 12, 18 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 12, 18 months ] [ Designated as safety issue: No ]

Enrollment: 420
Study Start Date: November 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E
ONO-2506PO in the presence of Riluzole
Drug: ONO-2506PO
1200 mg QD / 18 months
Placebo Comparator: P
Placebo in the presence of Riluzole
Drug: ONO-2506PO
0 mg QD / 18 months

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403104

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

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00403104     History of Changes
Other Study ID Numbers: ONO-2506POE014
Study First Received: November 22, 2006
Last Updated: June 12, 2012
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Switzerland: Swissmedic
Austria: Agency for Health and Food Safety
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Netherlands: Dutch Health Care Inspectorate

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-2506PO
Amyotrophic Lateral Sclerosis
ALS

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes
Riluzole
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 23, 2014