Mitochondrial Antioxidant therapy to Resolve Inflammation in Ulcerative Colitis (Mini-MARVEL): A Phase 2b feasibility randomised placebo controlled trial of oral MitoQ in mild-to-moderately active paediatric UC.
Mini-MARVEL aims to assess the acceptability and practicality of delivering the intervention (MitoQ or placebo as add-on therapy) in a multi-centre UK placebo-controlled RCT in paediatric UC, and to estimate parameters for a possible larger study of this add-on therapy to conventional medical therapy in a multi-centre RCT. We will also obtain information on possible effectiveness of the repurposed drug MitoQ as an add-on to standard therapy compared to placebo add-on in mild-moderately active paediatric UC, to investigate effectiveness, safety and tolerability of MitoQ in UC, and also the effect on steroid burden and quality of life (QoL).
Chief Investigator: Gwo-Tzer Ho
Number and location of participating sites (by region/ country): 10 UK sites
EudraCT number: 2021-005010-34
Funder: JP Moulton Foundation Trust
Start and End date
Of grant award: August 2019
Of recruitment: TBC
Current Status: In set up
Sponsor Representative: ACCORD https://www.accord.scot/
Gwo-Tzer Ho, Centre for Inflammation Research, QMRI, Edinburgh BioQuarter, 47 Little France Crescent, Edinburgh, EH16 4TJ, G.Ho@ed.ac.uk
Alix Macdonald, Edinburgh Clinical Trials Unit, University of Edinburgh, Nine Edinburgh Bioquarter, 9 Little France Road, EDINBURGH, EH16 4UX email@example.com
ECTU involvement: Trial management / Statistics / Database