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

Ono Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Treatments: Drug: ONO-2506PO

Study type: Interventional

Funder types: Industry

Identifiers

NCT00403104

ONO-2506POE014

Details and patient eligibility

About

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.

Enrollment: 420 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No 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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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420 participants in 2 patient groups, including a placebo group

E

Experimental group

Description:

ONO-2506PO in the presence of Riluzole

Treatment:

Drug: ONO-2506PO

Drug: ONO-2506PO

P

Placebo Comparator group

Description:

Placebo in the presence of Riluzole

Treatment:

Drug: ONO-2506PO

Drug: ONO-2506PO