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A clinical study investigating modafinil for the treatment of severe fatigue in patients with inflammatory bowel disease (MODIFI-IBD trial)
EU CTIS ID: 2026-525163-41-00
What this study is testing
To investigate efficacy of modafinil versus placebo for the treatment of severe fatigue in patients with quiescent IBD
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient is able and willing to provide written informed consent
- 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 6 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
- Fecal calprotectin <150 µg/g
You likely can't join if
- Contraindications for the use of modafinil, such as but not limited to uncontrolled hypertension and cardiac arrhythmia
- Patients using medication which interacts clinically significant with modafinil
- Patients using pharmacological agents with similar effects to modafinil, like central nervous system (CNS) stimulants or other wakefulness-promoting drugs such as methylphenidate and amphetamines
- Participation in another intervention study (excl. registries and post marketing studies)
- Pregnant at the moment of the screening visit or planning pregnancy within 2 months after last dose
- Planned surgery before or during study period that impacts ability to participate in this study, per investigator judgement
See the full eligibility criteria
- Patient is able and willing to provide written informed consent
- 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 6 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
- Fecal calprotectin <150 µg/g
- Stable IBD medication (or absence of IBD medication) for ≥3 months before randomization and no change in IBD medication planned for ≥3 months
- Contraindications for the use of modafinil, such as but not limited to uncontrolled hypertension and cardiac arrhythmia
- Patients using medication which interacts clinically significant with modafinil
- Patients using pharmacological agents with similar effects to modafinil, like central nervous system (CNS) stimulants or other wakefulness-promoting drugs such as methylphenidate and amphetamines
- Participation in another intervention study (excl. registries and post marketing studies)
- Pregnant at the moment of the screening visit or planning pregnancy within 2 months after last dose
- Planned surgery before or during study period that impacts ability to participate in this study, per investigator judgement
- Confirmed diagnosis of other potential causes of fatigue, such as anaemia, specific vitamin deficiencies as well as somatic or psychiatric comorbidities
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.