Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)

A Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of Randomization

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00403104

Enrollment

420

Registered

2006-11-23

Start date

2006-11-30

Completion date

2008-12-31

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 purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared with placebo group.

Interventions

DRUGONO-2506PO

1200 mg QD / 18 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

Inclusion criteria

1. Diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable or clinically definite ALS (according to WNF EL Escorial diagnostic criteria, revised according to the Airlie House Conference 1998) 2. Onset of muscle weakness within 14 months randomization 3. Concomitant standard Riluzole therapy (50mg twice daily)

Exclusion criteria

1. Presence of a tracheotomy, mechanical ventilation or non-invasive ventilation 2. Requirement for prescription drugs used for potential neuroprotective benefit -

Design outcomes

Primary

Measure	Time frame
Rate of decline of respiratory function determined as SVC over the 12 month treatment period	12 months

Secondary

Measure	Time frame
Survival	12, 18 months
Functional Assessment (ALSFRS-R)	12, 18 months
Muscle Strength (MRC muscle score)	12, 18 months
Quality of Life	12, 18 months

Countries

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

Outcome results

None listed

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