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NCT07295834

PHASE2

Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial

Sponsor: Imperial College London

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-02-01

Completion Date

2028-02-01

Last Updated

2025-12-22

Healthy Volunteers

Conditions

Crohn Disease (CD)Ulcerative Colitis (UC)Fatigue

Interventions

DRUG

Modafinil

100-300mg daily according to patient response

DRUG

Placebo

1-3 placebo capsules according to patient response

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)

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

Clinical Research Directory

Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (4)