NCT07295834Not yet recruitingPhase 2
Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial
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
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
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. Fatigue can be physical (e.g. feeling tired or weak) and mental (e.g. brain fog). However, there are no effective treatments for IBD fatigue. Modafinil is a medication that can rapidly improve fatigue. It usually acts within 30 minutes and improves wakefulness. It can also improve brain fog. Modafinil has been used for over 30 years in people with narcolepsy, which is a condition where people fall asleep during the day. Modafinil has also been used in people who do not have narcolepsy. This study will compare modafinil with a dummy tablet (placebo) in people with IBD. This is a feasibility study. This means it primarily aims to test whether a trial like this can be conducted in people with IBD. Half of the patients in the study will receive modafinil and half will receive placebo. Treatment will be 12 weeks. Patients will start by taking 1 tablet and will then increase to 2 tablets and then 3 tablets if needed. A computer will randomly allocate treatment, meaning there is an equal chance of being allocated modafinil or placebo. They will be followed up after 6 weeks and 12 weeks. Being a feasibility study, the investigators will measure how many patients consent to the study; how many complete treatment; and how acceptable the treatment is. Participants will complete a range of questionnaires measuring fatigue, mental health and gut health, primarily to look at the completeness and spread of data, and to obtain estimates of treatment effects and their variance. If feasible, this study will support a larger version of the trial.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 20 Nov 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Imperial College London
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07295834
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 1 Feb 2026 to the primary completion date, 1 Dec 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Currently enrolled in another drug trial or psychological therapy trial.
Other illness
- Diagnosis of drug or alcohol dependence syndrome according to patient report or GP record.
- Diagnosis of any dementia according to patient report or GP record.
- Diagnosis of bipolar disorder according to patient report or GP record.
- Patient-reported hypersensitivity to modafinil
- Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held.
Other
- Diagnosis of psychosis or schizophrenia according to patient report or GP record.
- Current active suicidal ideation on clinical assessment by study psychiatrist.
- Contraindications to the administration of modafinil, as per the current SmPC.
- Currently hospitalised for the treatment of IBD.
- Currently being prescribed a course of budesonide or reducing course of prednisolone for IBD.
- Planned change in IBD treatment within the next 12 weeks.
- Currently breastfeeding, pregnant or planning pregnancy.
- Diagnosis of indeterminate colitis
Who the study is looking for
- 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
- Current IBD Fatigue Assessment Scale score ≥11/20
- 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.
- Faecal calprotectin \<250mcg within the last 3 months
- Normal haemoglobin concentration (≥130g/L \[men\] and ≥120g/L \[women\]) within the last 3 months
- Thyroid stimulating hormone (TSH) level (0.4-4.0 mU/L) within last 3 months
- Serum total B12 concentration (≥180 nanograms/L) within last 3 months
- Able to provide written informed consent to enter the trial.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Mark's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guy's and St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| King's College Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.