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

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403104
• Other study ID #: ONO-2506POE014
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2006
• Last updated: June 12, 2012
• Start date: November 2006
• Est. completion date: December 2008

Study information

• Verified date: June 2012
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Switzerland: SwissmedicAustria: Agency for Health and Food SafetyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthNetherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• ONO-2506PO
1200 mg QD / 18 months
• ONO-2506PO
0 mg QD / 18 months

Locations

Country	Name	City	State
Austria	L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien	Wien
Belgium	UCL Saint-Luc	Brussels
Belgium	UZ Leuven	Leuven
France	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
Germany	Charite Campus Virchow, ALS Ambulanz	Berlin
Germany	Neurologische Universitatsklinik Bergmannsheil	Bochum
Germany	Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik	Erlangen
Germany	Martin-Luther-Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie	Halle
Germany	Medizinische Hochschule Hannover, Neurologische Klinik	Hannover
Germany	Interdisziplinares Zentrum fur Palliativmedizin	Munchen
Germany	Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm	Ulm
Germany	Deutsche Klinik fur Diagnostik, Fachbereich Neurologie	Wiesbaden
Italy	Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano	Milano
Italy	Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS	Pavia
Italy	Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette	Torino
Netherlands	Academic Medical Centre (AMC) Amsterdam - Dept of Neurology	Amsterdam
Netherlands	University Medial Center Utrecht	Utrecht
Switzerland	Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic	St. Gallen
United Kingdom	Academic Neuroscience Centre	London
United Kingdom	Royal Preston Hospital	Preston
United Kingdom	University of Sheffield - Academic Neurology Unit	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of decline of respiratory function determined as SVC over the 12 month treatment period		12 months	No
Secondary	Survival		12, 18 months	Yes
Secondary	Functional Assessment (ALSFRS-R)		12, 18 months	No
Secondary	Muscle Strength (MRC muscle score)		12, 18 months	No
Secondary	Quality of Life		12, 18 months	No