Clinical trial NCT00403104: Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: ONO-2506PO
Amyotrophic Lateral Sclerosis
ALS
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2006-11-23
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 -

Primary outcomes:
measure: Rate of decline of respiratory function determined as SVC over the 12 month treatment period
timeFrame: 12 months
Secondary outcomes:
measure: Survival
timeFrame: 12, 18 months
measure: Functional Assessment (ALSFRS-R)
timeFrame: 12, 18 months
measure: Muscle Strength (MRC muscle score)
timeFrame: 12, 18 months
measure: Quality of Life
timeFrame: 12, 18 months
Other outcomes:
Locations:
city: Wien
country: Austria
facility: L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien
city: Brussels
country: Belgium
facility: UCL Saint-Luc
city: Leuven
country: Belgium
facility: UZ Leuven
city: Lille Cedex
country: France
facility: Hopital Roger Salengro - Clinique Neurologique, Neurologie A
city: Limoges Cedex
country: France
facility: Hopital Duruytren
city: Marseille
country: France
facility: Hopital de la Timone
city: Montpellier cedex 5
country: France
facility: Hopital de Chauliac
city: Nice cedex 3
country: France
facility: Hopital l-Archet 1
city: Paris
country: France
facility: Hopital LaPitie Salpetriere
city: Berlin
country: Germany
facility: Charite Campus Virchow, ALS Ambulanz
city: Bochum
country: Germany
facility: Neurologische Universitatsklinik Bergmannsheil
city: Erlangen
country: Germany
facility: Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik
city: Halle
country: Germany
facility: Martin-Luther-Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Neurologische Klinik
city: Munchen
country: Germany
facility: Interdisziplinares Zentrum fur Palliativmedizin
city: Ulm
country: Germany
facility: Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm
city: Wiesbaden
country: Germany
facility: Deutsche Klinik fur Diagnostik, Fachbereich Neurologie
city: Milano
country: Italy
facility: Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano
city: Pavia
country: Italy
facility: Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS
city: Torino
country: Italy
facility: Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre (AMC) Amsterdam - Dept of Neurology
city: Utrecht
country: Netherlands
facility: University Medial Center Utrecht
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic
city: London
country: United Kingdom
facility: Academic Neuroscience Centre
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Sheffield
country: United Kingdom
facility: University of Sheffield - Academic Neurology Unit
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Tomohiro Kuwayama
role: STUDY_DIRECTOR
References: