Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial
Phase 2 · Testing Modafinil · 4 sites · Imperial College London
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Modafinil (a drug) as a possible treatment. Condition(s) listed: Crohn Disease (CD), Ulcerative Colitis (UC) and Fatigue.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Established diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) according to clinical notes
- Reported fatigue duration of 6 months or more
- Aged 18 years or over
Plus 7 more requirement(s). There are also 15 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 70 participants are expected to take part.
- Start date: 2026-02-01 (planned).
- Main results expected around 2027-12-01 (estimate from the record).
- 4 study sites listed in United Kingdom.
Main thing being measured
- Recruitment rate (2 years)
In the researchers’ words
Fatigue is a big problem in people with inflammatory bowel disease (IBD). Even when IBD is well controlled, 50% of patients remain fatigued most of the time.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Crohn Disease (CD); Ulcerative Colitis (UC); Fatigue |
| Lead sponsor | Imperial College London |
| Enrollment | 70 (estimated) |
| Start date | 2026-02-01 |
| Primary completion (est.) | 2027-12-01 |
| First posted | 2025-12-22 |
| Last updated | 2025-12-22 |
| Official title | A Multi-centre, Double-blind Randomised Controlled Trial to Compare Modafinil Versus Placebo Over 12 Weeks in Patients With Severe Fatigue and Inflammatory Bowel Disease (MFI): a Feasibility Study |
| ClinicalTrials.gov ID | NCT07295834 |
Interventions
- Modafinil (Drug)
100-300mg daily according to patient response - Placebo (Drug)
1-3 placebo capsules according to patient response
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Established diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) according to clinical notes 2. Reported fatigue duration of 6 months or more 3. Aged 18 years or over 4. Current IBD Fatigue Assessment Scale score ≥11/20 5. Use of contraception if female and of childbearing age. Female participants of childbearing age will require a negative serum/urine pregnancy test before starting the study and will also need to agree to use an acceptable form of contraception throughout the intervention period, e.g. long-acting reversible contraceptive. 6. Faecal calprotectin <250mcg within the last 3 months 7. Normal haemoglobin concentration (≥130g/L \[men\] and ≥120g/L \[women\]) within the last 3 months 8. Thyroid stimulating hormone (TSH) level (0.4-4.0 mU/L) within last 3 months 9. Serum total B12 concentration (≥180 nanograms/L) within last 3 months 10. Able to provide written informed consent to enter the trial. Exclusion Criteria: 1. Diagnosis of drug or alcohol dependence syndrome according to patient report or GP record. 2. Diagnosis of any dementia according to patient report or GP record. 3. Diagnosis of psychosis or schizophrenia according to patient report or GP record. 4. Diagnosis of bipolar disorder according to patient report or GP record. 5. Current active suicidal ideation on clinical assessment by study psychiatrist. 6. Current treatment with stimulant medication (e.g. methylphenidate), dopamine agonist (e.g. ropinirole), levo-dopa (L-DOPA), antipsychotic (e.g. olanzapine), avacopan, avaritinib, bosutinib, doravirine, grazoprevir, leniosilib, moboceritinib, Osimertinib, sofosbuvir, velpatasvir or voxilapravir 7. Contraindications to the administration of modafinil, as per the current SmPC. 8. Patient-reported hypersensitivity to modafinil 9. Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held. 10. Currently enrolled in another drug trial or psychological therapy trial. 11. Currently hospitalised for the treatment of IBD. 12. Currently being prescribed a course of budesonide or reducing course of prednisolone for IBD. 13. Planned change in IBD treatment within the next 12 weeks. 14. Currently breastfeeding, pregnant or planning pregnancy. 15. Diagnosis of indeterminate colitis
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | United Kingdom | |
| St Mark's Hospital | London | United Kingdom | |
| Guy's and St Thomas' NHS Foundation Trust | London | United Kingdom | |
| King's College Hospital NHS Foundation Trust | London | United Kingdom |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.