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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: |
NCT00694941 |
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Date of registration:
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06/06/2008 |
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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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A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)
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Scientific title:
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A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS) |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00694941 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, 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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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 Pharma UK |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
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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Adverse Events
[Time Frame: Oct 2013]
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Death
[Time Frame: Oct 2013]
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Tracheotomy or permanent assisted ventilation
[Time Frame: Oct 2013]
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Secondary ID(s)
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ONO-2506POE015
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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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