Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial) (NCT07582458) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial)
60 participantsStarted 2026-06-01
Plain-language summary
The goal of this clinical trial is to learn if modafinil can treat severe fatigue in adults aged 18 to 75 years with quiescent inflammatory bowel disease (IBD). The main questions it aims to answer are:
Does modafinil reduce fatigue more effectively than placebo, as measured by the mean difference in section I of the IBD-F questionnaire at week 8? Is modafinil safe and well tolerated in patients with quiescent IBD and severe fatigue?
Researchers will compare modafinil to placebo to see if modafinil improves fatigue outcomes.
Participants will:
attend one screening visit including assessment of disease activity, blood tests, stool testing, and an ECG; take modafinil or placebo for 8 weeks, starting at 100 mg daily with possible dose increases based on response and tolerability; complete online questionnaires at baseline, week 4, week 8, and week 12 about fatigue, quality of life, sleep, mood, and work productivity; be contacted regularly during the treatment period to discuss effect and side effects of the study medication; complete an online effort-based decision-making task at baseline and week 8.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing and able to provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study
* Age between 18 to 75 years at screening.
* ≥1 year diagnosis of IBD, based on a combination of clinical, endoscopic, histologic and radiologic criteria
* Chronic fatigue for at least six months
* Severe fatigue as confirmed with a score of ≥11 on section I of the IBD-F
* Clinically quiescent IBD with a Harvey Bradshaw Index (HBI) \<5 for CD patients or a Simple Colitis Clinical Activity Index (SCCAI) ≤2 for patients with UC or IBD-unclassified
* Faecal calprotectin \<250 µg/g
* Stable IBD medication for ≥3 months before screening visit and no change in IBD medication planned for ≥3 months
Exclusion Criteria:
* Contraindications for the use of modafinil, such as:
* Uncontrolled hypertension
* Cardiac arrhythmia
* A history of left ventricular hypertrophy or cor pulmonale, and in patients with mitral valve prolapse who have previously developed mitral valve prolapse syn-drome during treatment with central nervous system stimulants
* Patients with hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption
* Patients using medication which interacts clinically significant with modafinil, see section 3.3 'Mechanism of action \& Drug class'
* Patients using pharmacological agents with similar effects to modafinil, like central nerv-ous system (CNS) stimulants or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The mean difference in section I of the IBD-F questionnaire at week 8