Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial

Sponsor
Imperial College London
Study ID
NCT07295834
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Crohn Disease (CD)
  • Fatigue
  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Modafinil — DRUG
    100-300mg daily according to patient response
  • Placebo — DRUG
    1-3 placebo capsules according to patient response

Study Details

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.

Key Dates

First listed
Dec 22, 2025
Start date
Feb 1, 2026
Status verified
Dec 2025
Primary completion
Dec 1, 2027
Completion
Feb 1, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    1 capsule, increasing if needed after 2 weeks to 2 capsules, increasing if needed after 2 weeks to 3 capsules. Total treatment duration 12 weeks.
  • Active Comparator: Modafinil
    1 x 100mg, increasing if needed after 2 weeks to 2 x 100mg, increasing if needed after 2 weeks to 3 x 100mg. Total treatment duration 12 weeks.

Primary Outcome Measure

Recruitment rate [ Time Frame: 2 years ]

Central Contacts

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