ReMEdi
Research type
Research Study
Full title
ReMEdi - Randomised controlled trial of the safety and efficacy of PHOE-01 in ME/CFS with digital monitoring
IRAS ID
1010633
Contact name
Florian Herb
Contact email
Sponsor organisation
Alfred E. Tiefenbacher (GmbH & Co.)
Research summary
Myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS) is a poorly understood condition with limited treatment options that only manage symptoms. Due to the negative consequences of ME/CFS on the quality of life of the individual and their families there is a need for the development of further pharmacological treatments.
Currently there is no clinical evidence with the effectiveness of the drug called PHOE-01, so in order to fully understand the clinical value of treating moderate ME/CFS, we plan to conduct this clinical trial in an adult population of patients suffering from ME/CFS and willing to take part in the trial. PHOE-01 is an oral tablet that has been licensed for the symptomatic treatment of patients with Lambert-Eaton myasthenic syndrome (LEMS).
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0291
Date of REC Opinion
25 Oct 2024
REC opinion
Further Information Unfavourable Opinion