NCT00298662: Tacrolimus added to interferon beta for multiple sclerosis

NCT00298662 tested tacrolimus (Prograf) added to interferon beta-1b (Betaseron) in multiple sclerosis. The original 2012 report enrolled 25 patients and randomized them to lower or higher tacrolimus trough targets—1–5 or 5–10 ng/mL—while all received interferon beta-1b. It was a 38-week safety/tolerability study, not a placebo-controlled efficacy comparison. 1 2

Twenty patients completed the study. Three stopped combination treatment because of treatment-related adverse events while continuing monotherapy. Frequently reported events included injection-site reactions and headache, each in 17/25, influenza-like symptoms in 14/25, and diarrhea in 12/25. The small sample does not establish long-term safety. 2

Changes in disability score were not statistically significant, and MRI lesion counts were not improved. The absence of an interferon-only randomized control means the trial cannot establish that adding tacrolimus prevents relapses or disability better than standard treatment. Its useful contribution is the observed feasibility and adverse-event profile of this specific combination. 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00298662. Original registration; establishes the exact study identity and registered methods.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00298662. Original registration; establishes the exact study identity and registered methods.

2. Jacques et al. (2012), Multiple Sclerosis International, article 935921; DOI 10.1155/2012/935921. Original combination-treatment report with randomized dose groups, disposition, adverse events and exploratory clinical/MRI outcomes — Jacques et al. (2012), Multiple Sclerosis International, article 935921; DOI 10.1155/2012/935921. Original combination-treatment report with randomized dose groups, disposition…Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.