Mini MARVEL

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/

Chief Investigator

Gwo-Tzer Ho, Centre for Inflammation Research, QMRI, Edinburgh BioQuarter, 47 Little France Crescent, Edinburgh, EH16 4TJ, G.Ho@ed.ac.uk

Trial Manager

Alix Macdonald, Edinburgh Clinical Trials Unit, University of Edinburgh, Nine Edinburgh Bioquarter, 9 Little France Road, EDINBURGH, EH16 4UX  alix.macdonald@ed.ac.uk

ECTU involvement: Trial management / Statistics / Database

(UKCRC)