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Modafinil for Severe Fatigue in Patients with Quiescent Inflammatory Bowel Disease

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Stichting Radboud University Medical Center Nijmegen The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Rpeccopfn Zdibvzoudw Stdhlwekh Arnhem The Netherlands
Uxewxctxqpcg Micfwwn Cdiwsgw Gkorymhgz Groningen The Netherlands
Ajvbjppfo Ury Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.04.2026

Trial locations

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.

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 ID:
2026-525163-41-00
Protocol code:
2026-525163-41-00
Trial Phase:
Therapeutic use (Phase IV)

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