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

Phase 2

Completed

• Conditions: Amyotrophic Lateral Sclerosis (ALS)
• Interventions: Drug: ONO-2506PO

• Registration Number: NCT00694941
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.

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 Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-06
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-11
• Primary Completion: 2008-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E	ONO-2506PO	ONO-2506PO in the presence of Riluzole

Primary Outcome Measures

Name	Time	Method
Adverse Events	Oct 2013
Death	Oct 2013
Tracheotomy or permanent assisted ventilation	Oct 2013

Trial Locations

Locations (25)

Prof. Maloteaux, UCL Saint-Luc; 🇧🇪 Brussels, Belgium

Prof. Wim Robberecht, UZ Leuven; 🇧🇪 Leuven, Belgium

Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A; 🇫🇷 Lille Cedex, France

Prof. Philippe Couratier, Hopital Duruytren; 🇫🇷 Limoges Cedex, France

Prof. Jan Pouget, Hopital de la Timone; 🇫🇷 Marseille, France

Prof. William Camu, Hopital de Chauliac; 🇫🇷 Montpellier cedex 5, France

Prof. Claude Desnuelle, Hopital 1-Archet 1; 🇫🇷 Nice cedex 3, France

Prof. Vincent Meininger, Hopital LaPitie Salpetriere; 🇫🇷 Paris, France

Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz; 🇩🇪 Berlin, Germany

Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil; 🇩🇪 Bochum, Germany

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