ReMEdi - Randomised controlled trial of the safety and efficacy of PHOE-01 in ME/CFS with digital monitoring
| ISRCTN | ISRCTN74088209 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74088209 |
| IRAS number | 1010633 |
| Secondary identifying numbers | PHOE2024-01 |
- Submission date
- 23/05/2025
- Registration date
- 28/05/2025
- Last edited
- 25/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Deferred
- Condition category
- Nervous System Diseases
Plain English summary of protocol
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record by the end date of the deferral (24 Jan 2026)
Contact information
Principal Investigator
Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
| Phone | +44 (0)1865 618309 |
|---|---|
| beata.godlewska.ext@lindushealth.com |
Public, Scientific
Lindus Health, 2nd Floor, 90 Union Street
London
SE1 0NW
United Kingdom
| Phone | +44 800 086 8449 |
|---|---|
| remedi@lindushealth.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | ReMEdi - Randomised controlled trial of the safety and efficacy of PHOE-01 in ME/CFS with digital monitoring |
| Study acronym | ReMEdi |
| Study objectives | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record by the end date of the deferral (24 Jan 2026) |
| Ethics approval(s) |
1. Approved 22/01/2025, South Central - Oxford B Research Ethics Committee (Health Research Authority, 2 Redman Place, London, E20 1JQ, United Kingdom; +44 207 104 8134; oxfordb.rec@hra.nhs.uk), ref: 24/SC/0409 2. Approved 24/01/2025, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 20 3080 6000; info@mhra.gov.uk), ref: CTA 17683/0223/001-0001 |
| Health condition(s) or problem(s) studied | Myalgic Encephalomyelitis/Chronic Fatigue Syndrome |
| Intervention | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record by the end date of the deferral (24 Jan 2026) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Dose response |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record by the end date of the deferral (24 Jan 2026) |
| Primary outcome measure | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record by the end date of the deferral (24 Jan 2026) |
| Secondary outcome measures | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record by the end date of the deferral (24 Jan 2026) |
| Overall study start date | 01/03/2024 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 25 |
| Key inclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record by the end date of the deferral (24 Jan 2026) |
| Key exclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record by the end date of the deferral (24 Jan 2026) |
| Date of first enrolment | 05/02/2025 |
| Date of final enrolment | 31/10/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SE1 0HR
United Kingdom
Sponsor information
Industry
Van-der-Smissen-Strasse 1
Hamburg
22767
Germany
| Phone | +49 40 44 18 09 0 |
|---|---|
| clinical_studies@tiefenbacher.com | |
| Website | https://aet.eu/ |
"ROR" |
https://ror.org/05cs0pa90 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Full trial details will be published up to 30 months after the end of the trial. Publication of some trial details is deferred because of the high commercial sensitivity of this study. Results will be posted on or after the date of publication of full trial details. |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available because of their commercial sensitivity |
Editorial Notes
25/07/2025: The date of final enrolment was changed from 06/06/2025 to 31/10/2025.
17/07/2025: The completion date was changed from 15/09/2025 to 31/12/2025.
17/06/2025: The sponsor contact was amended.
27/05/2025: Trial's existence confirmed by MHRA.
