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

Primary Purpose

Amyotrophic Lateral Sclerosis (ALS)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ONO-2506PO
ONO-2506PO
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis (ALS) focused on measuring ONO-2506PO, Amyotrophic Lateral Sclerosis, ALS

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien
  • UCL Saint-Luc
  • UZ Leuven
  • Hopital Roger Salengro - Clinique Neurologique, Neurologie A
  • Hopital Duruytren
  • Hopital de la Timone
  • Hopital de Chauliac
  • Hopital l-Archet 1
  • Hopital LaPitie Salpetriere
  • Charite Campus Virchow, ALS Ambulanz
  • Neurologische Universitatsklinik Bergmannsheil
  • Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik
  • Martin-Luther-Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie
  • Medizinische Hochschule Hannover, Neurologische Klinik
  • Interdisziplinares Zentrum fur Palliativmedizin
  • Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm
  • Deutsche Klinik fur Diagnostik, Fachbereich Neurologie
  • Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano
  • Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS
  • Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette
  • Academic Medical Centre (AMC) Amsterdam - Dept of Neurology
  • University Medial Center Utrecht
  • Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic
  • Academic Neuroscience Centre
  • Royal Preston Hospital
  • University of Sheffield - Academic Neurology Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

E

P

Arm Description

ONO-2506PO in the presence of Riluzole

Placebo in the presence of Riluzole

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Survival
Functional Assessment (ALSFRS-R)
Muscle Strength (MRC muscle score)
Quality of Life

Full Information

First Posted
November 22, 2006
Last Updated
June 12, 2012
Sponsor
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00403104
Brief Title
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

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis (ALS)
Keywords
ONO-2506PO, Amyotrophic Lateral Sclerosis, ALS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E
Arm Type
Experimental
Arm Description
ONO-2506PO in the presence of Riluzole
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
Placebo in the presence of Riluzole
Intervention Type
Drug
Intervention Name(s)
ONO-2506PO
Intervention Description
1200 mg QD / 18 months
Intervention Type
Drug
Intervention Name(s)
ONO-2506PO
Intervention Description
0 mg QD / 18 months
Primary Outcome Measure Information:
Title
Rate of decline of respiratory function determined as SVC over the 12 month treatment period
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Survival
Time Frame
12, 18 months
Title
Functional Assessment (ALSFRS-R)
Time Frame
12, 18 months
Title
Muscle Strength (MRC muscle score)
Time Frame
12, 18 months
Title
Quality of Life
Time Frame
12, 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Presence of a tracheotomy, mechanical ventilation or non-invasive ventilation Requirement for prescription drugs used for potential neuroprotective benefit -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomohiro Kuwayama
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
UCL Saint-Luc
City
Brussels
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hopital Roger Salengro - Clinique Neurologique, Neurologie A
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Duruytren
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hopital de Chauliac
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital l-Archet 1
City
Nice cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital LaPitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Charite Campus Virchow, ALS Ambulanz
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Neurologische Universitatsklinik Bergmannsheil
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Martin-Luther-Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Neurologische Klinik
City
Hannover
ZIP/Postal Code
30623
Country
Germany
Facility Name
Interdisziplinares Zentrum fur Palliativmedizin
City
Munchen
Country
Germany
Facility Name
Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Deutsche Klinik fur Diagnostik, Fachbereich Neurologie
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano
City
Milano
ZIP/Postal Code
20149
Country
Italy
Facility Name
Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Academic Medical Centre (AMC) Amsterdam - Dept of Neurology
City
Amsterdam
Country
Netherlands
Facility Name
University Medial Center Utrecht
City
Utrecht
Country
Netherlands
Facility Name
Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Academic Neuroscience Centre
City
London
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR29HT
Country
United Kingdom
Facility Name
University of Sheffield - Academic Neurology Unit
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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