A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)

June 12, 2012 updated by: Ono Pharmaceutical Co. Ltd
The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an extension study which consists of two phases:

Double-blind phase; Patients will continue to take blinded study medication, as allocated in study ONO-2506POE014 by the central randomization system, in the presence of stable standard Riluzole therapy, until un-blinding of the study results.

Open label phase; Patients who were allocated to ONO-2506PO in the ONO-2506POE014 study will be offered entry into the open label phase of ONO-2506POE015 study and will continue to take 1200 mg of ONO-2506PO for the duration of their participation in the study, in the presence of stable standard Riluzole therapy. Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Prof. Maloteaux, UCL Saint-Luc
      • Leuven, Belgium
        • Prof. Wim Robberecht, UZ Leuven
  • France
      • Lille Cedex, France
        • Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A
      • Limoges Cedex, France
        • Prof. Philippe Couratier, Hopital Duruytren
      • Marseille, France
        • Prof. Jan Pouget, Hopital de la Timone
      • Montpellier cedex 5, France
        • Prof. William Camu, Hopital de Chauliac
      • Nice cedex 3, France
        • Prof. Claude Desnuelle, Hopital 1-Archet 1
      • Paris, France
        • Prof. Vincent Meininger, Hopital LaPitie Salpetriere
  • Germany
      • Berlin, Germany
        • Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz
      • Bochum, Germany
        • Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil
      • Erlangen, Germany
        • Professor Dieter Heuss, Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik
      • Halle, Germany
        • Prof. Stephan Zierz, Martin Luther Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie
      • Hannover, Germany
        • Prof. Reinhard Dengler, Medizinische Hochschule Hannover, Neurologische Klinik
      • Munchen, Germany
        • Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin
      • Ulm, Germany
        • Prof. Albert Ludolph, Klinik und Poliklinikfur Neurologie der Universitat Ulm-Univeritatsklinikum Ulm
      • Wiesbarden, Germany
        • Dr. Berthold Schrank, Deutsche Klinik fur Diagnostik, Fachbereich Neurologie
  • Italy
      • Milano, Italy
        • Prof. Vincenzo Silani, Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano
      • Pavia, Italy
        • Dr. Gabriele Mora, Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS
      • Torino, Italy
        • Prof. Adriano Chio, Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette
  • Netherlands
      • Amsterdam, Netherlands
        • Prof Marianne de Visser, Academic Medical Centre (AMC) Amsterdam - Dept of Neurology
      • Utrecht, Netherlands
        • Prof. Leonard H Van Den Berg, University Medical Center Utrecht
  • Switzerland
      • St. Gallen, Switzerland
        • Dr. Markus Weber, Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic
  • United Kingdom
      • London, United Kingdom
        • Prof. Nigel Leigh, Academic Neuroscience Centre
      • Preston, United Kingdom
        • Prof. Douglas Mitchell, Royal Preston Hospital
      • Sheffield, United Kingdom
        • Dr. Chris McDermott, Royal Hallamshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult male and female patients with diagnosis of ALS over the age of 18 years.
  • Previous randomization and completion of the last visits in ONO-2506POE014 study.
  • Patients whom the investigator has no concern and judges tolerable for the continued treatment with ONO-2506PO and Riluzole from a risk and benefit point of view.

Exclusion Criteria:

  • A clinically relevant medical history or presence of cardiovascular, gastrointestinal, renal, hepatic, endocrine/metabolic, neurologic, lymphatic, haematologic, immunologic, musculoskeletal, connective tissue, dermatologic, genito/urinary, psychiatric diseases or disorders that, in the opinion of the investigator may pose an unwarranted risk to the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E
ONO-2506PO in the presence of Riluzole
Drug: ONO-2506PO
1200mg QD / 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: Oct 2013
Oct 2013
Death
Time Frame: Oct 2013
Oct 2013
Tracheotomy or permanent assisted ventilation
Time Frame: Oct 2013
Oct 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Tomohiro Kuwayama, Ono Pharma UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 6, 2008

First Submitted That Met QC Criteria

June 10, 2008

First Posted (Estimate)

June 11, 2008

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-2506POE015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amyotrophic Lateral Sclerosis (ALS)

Clinical Trials on ONO-2506PO

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe