AuthorisedPhase II and Phase III (Integrated)Interventional

Modafinil for debilitating fatigue in quiescent inflammatory bowel disease: a multicentre, randomised, double-blind, placebo-controlled, clinical trial (MODIFI-IBD trial)

This research, called the MODIFI-IBD trial, is investigating if modafinil, a medicine, can help adult patients who have inflammatory bowel disease (IBD) but are not currently experiencing a flare-up of their symptoms. Many people with IBD suffer from severe tiredness, known as fatigue. The study aims to find out if taking modafinil lessens this tiredness more effectively than a placebo (a pill with no active medicine). It's a 'double-blind' study, meaning neither the patients nor the doctors know if participants are receiving modafinil or the placebo, to ensure the results are fair. The main goal is to measure how much patients' fatigue improves over eight weeks.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Radboud universitair medisch centrum Stichting

Enrolment target

Start

04 May 2026

Inflammatory bowel disease, Fatigue

What is this study about?

This study is called the MODIFI-IBD trial. It's looking into a common and often distressing problem for people with inflammatory bowel disease (IBD), even when their condition is otherwise stable: extreme tiredness, also known as fatigue. Many patients find this fatigue significantly impacts their daily lives.

The researchers want to see if a medication called modafinil can help reduce this debilitating tiredness. Modafinil is already used for other conditions where people feel very sleepy. In this study, some participants will receive modafinil tablets, while others will receive a 'placebo' – a dummy pill that looks exactly like modafinil but contains no active medicine. This allows the researchers to fairly compare the effects of the actual drug against what might happen naturally or from simply taking a pill.

This study is designed to be 'double-blind', which means neither the patients nor their doctors will know whether they are taking modafinil or the placebo. This is a standard and important part of medical research to make sure the results are as unbiased and accurate as possible. The main thing they're looking at is how much a patient's fatigue improves after eight weeks of treatment, using special questionnaires developed for people with IBD.

Key takeaways

This study investigates a new treatment for severe tiredness (fatigue) in IBD patients.
It uses modafinil, a medicine, compared to a dummy pill (placebo).
Neither patients nor doctors will know who gets the real medicine (double-blind).
The main goal is to see if fatigue improves after 8 weeks.
Participation involves taking tablets and completing questionnaires over several months.
It's for adults with inactive IBD who are experiencing significant fatigue.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 or older. There is no upper age limit, meaning older adults can also participate. The study is open to both men and women.

A key requirement is that you must have been diagnosed with inflammatory bowel disease (IBD). Importantly, your IBD should be "quiescent," which means your condition is currently not active or flaring up, though you are still experiencing significant fatigue.

There will be other medical checks to make sure the study is a safe and suitable option for you. These might include reviewing your general health and any other medications you are taking.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of Inflammatory Bowel Disease (IBD)?
Is your IBD currently in a 'quiet' phase (not actively flaring)?
Are you experiencing significant tiredness or fatigue?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve several visits to a clinic over approximately three months. You will be given either modafinil tablets or a placebo (dummy pill) to take regularly. Neither you nor your study doctor will know which one you are taking.

Throughout the study, you'll be asked to complete various questionnaires. These will help the researchers understand how your fatigue is changing, as well as looking at your quality of life, sleep patterns, mood, and how your IBD symptoms are affecting you. You might also be asked to do some simple online tasks to see how your motivation and effort are affected.

Researchers will also be closely monitoring any side effects you experience. There will be follow-up appointments after you finish taking the medication to ensure your well-being. The exact number of visits and tests will be explained in detail if you are considered for the study.

Potential risks and benefits

Taking part in this study might offer you the potential benefit of improved fatigue if you receive modafinil and it proves effective. You will also contribute valuable information that could help many others with IBD in the future. However, there's no guarantee you will personally benefit, as you might receive the placebo or experience side effects. Potential risks include experiencing side effects from modafinil, which your doctor will discuss with you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is modafinil?

Modafinil is a type of medicine that helps to promote wakefulness. It's sometimes used for conditions where people experience excessive daytime sleepiness.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the actual medicine fairly.

What does 'double-blind' mean?

Double-blind means that neither you nor your study doctor will know if you are taking the active medicine (modafinil) or the placebo. This helps make the study results more reliable.

Why focus on fatigue in IBD?

Fatigue is a very common and difficult symptom for people with IBD, even when their other symptoms are under control. This study aims to find ways to help manage it.

How long will the study last if I join?

The main part of the study where you take medication is for 8 weeks, with follow-up appointments extending the overall duration to about 12-30 days post-treatment.