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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1010633 |
| Protocol serial number | PHOE2024-01 |
| Sponsor | Alfred E. Tiefenbacher (Germany) |
| Funder | Alfred E. Tiefenbacher |
- Submission date
- 23/05/2025
- Registration date
- 28/05/2025
- Last edited
- 06/11/2025
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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 |
| 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(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) |
| Key secondary outcome measure(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) |
| Completion date | 30/04/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 | 31/01/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
SE1 0HR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/11/2025: The following changes were made to the trial record:
1. The date of final enrolment was changed from 31/10/2025 to 31/01/2026.
2. The completion date was changed from 31/12/2025 to 30/04/2026.
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.
