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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00574041 |
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Date of registration:
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12/12/2007 |
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Primary sponsor: |
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Public title:
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How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose
TODAY |
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Scientific title:
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An Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY) |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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19 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00574041 |
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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 Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Contacts
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Name:
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Biogen-Idec Investigator |
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Address:
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Telephone:
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Email:
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Affiliation:
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Biogen Idec |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of clinically-definite relapsing-remitting multiple sclerosis
Exclusion Criteria:
- Any Product Information-specified contraindications to interferon-beta therapy, or
other medical factors which, in the opinion of the investigator, make the subject
unsuitable for interferon-beta therapy
- Use of AVONEX, but not other interferon therapies, in the 3 months prior to
randomisation into the study
- A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia,
septicemia) within 30 days prior to randomisation.
- History of seizure in the 3 months prior to randomisation
- History of suicidal ideation or severe depression within the 3 months prior to
randomisation.
- Other inclusion and exclusion criteria may apply per study protocol
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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Relapsing Remitting Multiple Sclerosis
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Intervention(s)
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Drug: Interferon beta-1a
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Primary Outcome(s)
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To assess the mean severity of episodes of FLS during the 4 week titration phase
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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To assess the mean severity and duration of FLS episodes in post-titration phase
[Time Frame: throughout study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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