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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00694941

Enrollment

Registered

2008-06-11

Start date

2008-06-30

Completion date

Unknown

Last updated

2012-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Keywords

ONO-2506PO, Amyotrophic Lateral Sclerosis, ALS

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 Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.

Interventions

DRUGONO-2506PO

1200mg QD / 5 years

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse Events	Oct 2013
Death	Oct 2013
Tracheotomy or permanent assisted ventilation	Oct 2013

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026