Hepatic Safety of Adjunctive High-Dose Melatonin in Participants Receiving Ocrelizumab for Primary Progressive Multiple Sclerosis: Liver Toxicity Findings from a Phase I/II Randomised Clinical Trial (
4 days ago
- #melatonin
- #liver toxicity
- #multiple sclerosis
- The MELATOMS-1 study evaluated high-dose melatonin (300 mg/day) as adjunct therapy for primary progressive multiple sclerosis (PP-MS) patients on ocrelizumab.
- The trial was prematurely halted due to hypertransaminasemia (liver toxicity) in three out of four melatonin-treated patients, all of whom were women on polymedication.
- Liver toxicity resolved after melatonin discontinuation, suggesting a potential drug-drug interaction via shared CYP450 metabolic pathways.
- The only male participant, not on medications sharing melatonin's metabolic pathway, experienced no liver-related adverse events.
- Findings indicate caution is needed with high-dose melatonin in polymedicated patients due to possible hepatic overload from pharmacokinetic interactions.
- The study highlights the need for further research to establish safety guidelines for melatonin use in such populations.