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

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

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 Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.

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

Conditions
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Amyotrophic Lateral Sclerosis (ALS)

Intervention / Treatment
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* Drug: ONO-2506PO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | Oct 2013 | 
| Death |  | Oct 2013 | 
| Tracheotomy or permanent assisted ventilation |  | Oct 2013 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ONO-2506PO, Amyotrophic Lateral Sclerosis, ALS