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Modafinil for Severe Fatigue in Patients with Quiescent Inflammatory Bowel Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying inflammatory bowel disease, a long-term condition that causes swelling and irritation in the gut, and fatigue, which means severe tiredness that does not improve with rest. The treatment being tested is modafinil, taken by mouth as a tablet, compared with placebo. The purpose of the study is to see whether modafinil can help reduce severe fatigue in people whose inflammatory bowel disease is not active.

People taking part will receive study tablets over a period of several weeks. During the study, there will be follow-up visits at different times so that changes in tiredness and general well-being can be checked, and safety will also be monitored. Some people will receive modafinil and some will receive placebo, but the treatment is assigned by chance.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of the study

    You enter the study and begin treatment for severe fatigue linked to inflammatory bowel disease, which means a long-term condition that affects the intestines.

    You are assigned to receive either modafinil or placebo. A placebo is a tablet that looks the same as the study medicine but does not contain the active medicine.

    The study is double-blind, which means that you do not know which treatment you receive, and the study team also does not know during the trial.

  2. Step 2

    Treatment period

    You take 400 mg of the study medicine or placebo by mouth once daily.

    You continue this daily treatment for 8 weeks.

  3. Step 3

    Week 4 visit

    At week 4, your condition is checked with questionnaires about fatigue, bowel-related symptoms, quality of life, sleep, mood, anxiety, and daily work ability.

    The questionnaires used at this time are IBDQ (a questionnaire about the effect of bowel disease on daily life), PHQ-9 (a questionnaire about low mood), GAD-7 (a questionnaire about anxiety), FACIT-F (a fatigue questionnaire), and IBD-F section i (the first part of a fatigue questionnaire for people with bowel disease).

  4. Step 4

    Week 8 visit

    At week 8, you complete the main study assessment.

    Your fatigue is measured again using IBD-F section i, which is the main result the study is looking at.

    You also complete questionnaires about bowel disease impact, quality of life, sleep, mood, anxiety, and daily work ability. These include IBDQ, EQ-5D-5L (a questionnaire about general health and daily well-being), PSQI (a questionnaire about sleep quality), PHQ-9, GAD-7, iPCQ (a questionnaire about time and money lost because of health problems), and FACIT-F.

    An online task may also be used to look at how you respond to effort and reward, which means how you react to tasks that take effort and may lead to a reward.

    Blood-based markers may also be studied to see whether they can help identify fatigue in people with inflammatory bowel disease.

  5. Step 5

    Week 12 follow-up

    At week 12, you complete follow-up assessments after the treatment period.

    You are asked again to complete questionnaires about bowel disease impact, quality of life, mood, anxiety, daily work ability, fatigue, and sleep where specified.

    These include IBDQ, EQ-5D-5L, PHQ-9, GAD-7, iPCQ, FACIT-F, and IBD-F section i.

  6. Step 6

    Safety follow-up after treatment

    After the end of treatment, you are followed for 30 days for safety checks.

    During this time, any side effects are recorded, including side effects that start during treatment, serious side effects, important medical events, and side effects that lead to stopping modafinil.

Who can join the trial?

10 criteria

  • The person must be able and willing to give written informed consent, meaning they understand the study and agree to take part by signing a form.
  • The person must be between 18 and 75 years old at the time of screening, which is the first study checkup.
  • The person must have had inflammatory bowel disease (IBD) for at least 1 year, based on medical findings from doctor examination, scope tests, tissue tests, and imaging tests.
  • The person must have had chronic fatigue, meaning ongoing tiredness, for at least 6 months.
  • The person must have severe fatigue, shown by a score of 11 or higher on section I of the IBD-F questionnaire, which measures fatigue in people with IBD.
  • The person must have quiet or inactive IBD, meaning the bowel disease is not currently active:
    • For Crohn’s disease, the Harvey Bradshaw Index (HBI) must be less than 5. This is a score that shows how active Crohn’s disease is.
    • For ulcerative colitis or IBD not clearly classified, the Simple Colitis Clinical Activity Index (SCCAI) must be 2 or lower. This is a score that shows how active the disease is.
    • The person must have a fecal calprotectin level below 150 µg/g. Fecal calprotectin is a stool test that helps show inflammation in the bowel.
    • The person must have been on the same IBD medication, or no IBD medication, for at least 3 months before being assigned to a study group.
    • No change in IBD medication should be planned for at least 3 more months.

Who cannot join the trial?

7 criteria

  • Any reason that makes modafinil unsafe to use, including uncontrolled high blood pressure or cardiac arrhythmia (an irregular heartbeat).
  • Use of any medicine that has a clinically significant interaction with modafinil, meaning a drug combination that could cause important harm or make one of the medicines work badly.
  • Use of medicines with effects similar to modafinil, such as central nervous system stimulants or other wakefulness-promoting drugs, including methylphenidate and amphetamines.
  • Participation in another intervention study, which means another study where the person is receiving a treatment or procedure; this does not include registries or post-marketing studies.
  • Being pregnant at the screening visit, or planning to become pregnant within 2 months after the last dose of the study medicine.
  • A planned surgery before or during the study period that would make it hard to take part in the study, based on the investigator's judgment.
  • A confirmed other cause of fatigue, such as anemia (low red blood cells), specific vitamin deficiencies, or other physical or mental health conditions that could explain the tiredness.
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Investigated drugs

Modafinil is a medicine taken by mouth that was being tested in this trial to help with severe fatigue in people with inactive inflammatory bowel disease. It is a stimulant-like medicine that can help improve wakefulness and reduce tiredness, so the study looked at whether it could make patients feel less exhausted during the day.

What is already known about the treatment

  • Modafinil

    Modafinil is taken by mouth as a tablet, usually swallowed with water, and in this trial it was given as an oral medicine. It is an approved and well-studied drug in medical literature, mainly used to help people stay awake, and it has also been studied for fatigue in other conditions. Its main uses are narcolepsy, sleepiness caused by sleep disorders, and shift-work sleep problems, and it belongs to the wakefulness-promoting medicine group, also called a central nervous system stimulant-like agent. At the molecular level, modafinil mainly increases the activity of brain chemicals involved in alertness, especially by reducing the removal of dopamine, which helps improve wakefulness and may lessen tiredness.

  • Placebo

    Placebo is taken by mouth in the same way as the active study medicine, usually as a tablet or capsule that looks similar but does not contain an active drug. It is used only in research studies and has no therapeutic use in medical practice, but it is important for comparing results fairly in clinical trials. Because it has no active ingredient, it does not act on the body through a medicine mechanism and does not belong to a pharmacological treatment class.

Investigated diseases

  • Inflammatory bowel disease

    Inflammatory bowel disease is a group of long-term conditions that cause ongoing inflammation in the digestive tract. It usually develops in episodes, with periods when symptoms worsen and periods when they improve. Over time, the inflammation can come and go, and some people may have long stretches with few or no symptoms. It can affect different parts of the bowel and may gradually change the way the digestive system works.

  • Fatigue

    Fatigue is a persistent feeling of tiredness, low energy, or exhaustion that is not relieved by rest. It can develop gradually or appear after periods of illness or stress. When fatigue becomes long-lasting, it may interfere with daily activities and can fluctuate in intensity from day to day.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2026-525163-41-00Protocol code2026-525163-41-00Estimated enrolment60 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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