A Phase 4 interventional study of Interferon-beta-1a and Simvastatin in Multiple Sclerosis, sponsored by Biogen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2010-10-15.
Sponsored by Biogen · Phase 4, Interventional, and Treatment
This study is to find out if there is any benefit to adding Simvastatin to Interferon-beta-1a in patients with Multiple Sclerosis.
This is a multi-centre, double blind, placebo controlled, randomised, parallel group, phase 4 study. Following three months treatment with Interferon beta 1a (Avonex) patients will be randomised for treatment with simvastatin or placebo as an add-on to interferon -beta-1a (AvonexÒ). Patients will start treatment with 40 mg peroral simvastatin daily or identically appearing placebo for one month. Hereafter, patients will escalate dosage to 80 mg daily. The patients will be examined clinically at baseline and at, 3, 4, 6, 9, 12 and 15 months. Patients who attend visit 5 (15 months) before the last patient has attended this visit will be asked to attend additional visits (visits 6+) until the last patient has attended visit 5. Clinical examination will be performed, for applicable patients, at 3 month intervals until the end of the study. This will be a maximum of two years, i.e. no more than eight additional visits. Laboratory assessments will be performed at screening 3, 4, 6, 9, 12 and 15 months after baseline, and for applicable patients additionally at 3 month intervals until end of study. MRI will be performed (T1-weighted and T2-weighted) at randomisation (3 months after baseline) and 12 months hereafter.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 380 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
interferon beta-1a and Simvastatin
Drug: Interferon-beta-1a · Drug: Simvastatin
Interferon beta-1a and Placebo
Drug: Interferon-beta-1a · Drug: Placebo
dosage and frequency as per label
Also known as: Avonex
dosage and frequency as per Biogen Idec protocol
dosage and frequency the same as simvastatin as per Biogen Idec Protocol
The time to first documented relapse
Time frame: months 4, 6, 9, 12, and every 3 months from months 18-39
3Annual rate of documented relapses after randomisation
Time frame: months 4, 6, 9, 12, and every 3 months from months 18-39
Number of new and/or enlarging lesions on T2-weighted MRI based on MRI done 12 months following randomisation compared with MRI done at time of randomisation
Time frame: month 15
Proportion of patients without disease activity after randomisation (i.e. no relapses, no increase in EDSS score and no increase in enlarging or new T2 lesions).
Time frame: months 4, 6, 9, 12, and every 6 months from months 18-39
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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