How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose
Phase 4
Terminated
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Interventions
- Registration Number
- NCT00574041
- Lead Sponsor
- Biogen
- Brief Summary
This study is to find out if starting at low dose Avonex and slowly increasing to full dose will improve flu like symptoms as a side effect of Avonex treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Interferon beta-1a titrated dose of Avonex 2 Interferon beta-1a full dose Avonex
- Primary Outcome Measures
Name Time Method To assess the mean severity of episodes of FLS during the 4 week titration phase 4 weeks
- Secondary Outcome Measures
Name Time Method To assess the mean severity and duration of FLS episodes in post-titration phase throughout study
Trial Locations
- Locations (1)
Coordinating Research Site
🇦🇺Malvern, Victoria, Australia