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)
The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.
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ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be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.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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