Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial)

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.

NCT Number	NCT07582458
Lead Sponsor	Radboud University Medical Center
Conditions	Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Chronic Fatigue
Enrollment	60 participants
Start Date	2026-06-01
Primary Completion	2027-02-01 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-05-22