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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00403104 |
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Date of registration:
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22/11/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
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Scientific title:
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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 |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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420 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00403104 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Austria
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Belgium
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France
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Germany
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Italy
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Netherlands
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Switzerland
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United Kingdom
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Contacts
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Name:
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Tomohiro Kuwayama |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ono Pharmaceutical Co. Ltd |
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Key inclusion & exclusion criteria
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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 -
Age minimum:
18 Years
Age maximum:
74 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis (ALS)
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Intervention(s)
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Drug: ONO-2506PO
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Primary Outcome(s)
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Rate of decline of respiratory function determined as SVC over the 12 month treatment period
[Time Frame: 12 months]
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Secondary Outcome(s)
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Functional Assessment (ALSFRS-R)
[Time Frame: 12, 18 months]
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Muscle Strength (MRC muscle score)
[Time Frame: 12, 18 months]
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Quality of Life
[Time Frame: 12, 18 months]
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Survival
[Time Frame: 12, 18 months]
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Secondary ID(s)
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ONO-2506POE014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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