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

NCT00403104 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2012-06-13

No results posted yet for this study

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.

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

ONO-2506PO

1200 mg QD / 18 months

DRUG

ONO-2506PO

0 mg QD / 18 months

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Tomohiro Kuwayama · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00403104 on ClinicalTrials.gov