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

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694941
• Other study ID #: ONO-2506POE015
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2008
• Last updated: June 12, 2012
• Start date: June 2008

Study information

• Verified date: June 2012
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Switzerland: SwissmedicItaly: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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 Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• ONO-2506PO
1200mg QD / 5 years

Locations

Country	Name	City	State
Belgium	Prof. Maloteaux, UCL Saint-Luc	Brussels
Belgium	Prof. Wim Robberecht, UZ Leuven	Leuven
France	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
Germany	Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz	Berlin
Germany	Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil	Bochum
Germany	Professor Dieter Heuss, Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik	Erlangen
Germany	Prof. Stephan Zierz, Martin Luther Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie	Halle
Germany	Prof. Reinhard Dengler, Medizinische Hochschule Hannover, Neurologische Klinik	Hannover
Germany	Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin	Munchen
Germany	Prof. Albert Ludolph, Klinik und Poliklinikfur Neurologie der Universitat Ulm-Univeritatsklinikum Ulm	Ulm
Germany	Dr. Berthold Schrank, Deutsche Klinik fur Diagnostik, Fachbereich Neurologie	Wiesbarden
Italy	Prof. Vincenzo Silani, Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano	Milano
Italy	Dr. Gabriele Mora, Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS	Pavia
Italy	Prof. Adriano Chio, Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette	Torino
Netherlands	Prof Marianne de Visser, Academic Medical Centre (AMC) Amsterdam - Dept of Neurology	Amsterdam
Netherlands	Prof. Leonard H Van Den Berg, University Medical Center Utrecht	Utrecht
Switzerland	Dr. Markus Weber, Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic	St. Gallen
United Kingdom	Prof. Nigel Leigh, Academic Neuroscience Centre	London
United Kingdom	Prof. Douglas Mitchell, Royal Preston Hospital	Preston
United Kingdom	Dr. Chris McDermott, Royal Hallamshire Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		Oct 2013	Yes
Primary	Death		Oct 2013	Yes
Primary	Tracheotomy or permanent assisted ventilation		Oct 2013	Yes