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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: |
NCT00544037 |
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Date of registration:
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15/10/2007 |
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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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BENEFIT Extension Study
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Scientific title:
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Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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283 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00544037 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Austria
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Belgium
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Canada
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Czech Republic
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Denmark
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Finland
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France
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Germany
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Hungary
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Israel
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Italy
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Netherlands
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Norway
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Poland
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Portugal
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Slovenia
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Spain
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Sweden
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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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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients randomized and treated at least once in study 304747
Exclusion Criteria:
- Medical, psychiatric or other conditions that compromise the patient's ability to
understand the purpose of the study
Age minimum:
23 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Interferon beta-1b (Betaseron, BAY86-5046)
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Primary Outcome(s)
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To obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study
[Time Frame: End of Study]
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Secondary ID(s)
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311129
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91713
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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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