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

Starting soon · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Chronic Fatigue

In brief

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.

Key facts

Study ID: NCT07582458
Run by: Radboud University Medical Center
People needed: 60
Starts: 2026-06-01
Expected to finish: 2027-06-01
Last updated by the study team: 2026-05-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 other wakefulness-promoting drugs such as methylphenidate and amphetamines
Surgery before or during study period that impacts ability to participate in this study, per investigator judgement
Participation in another intervention study (excl. registries and post marketing studies)
Pregnancy or nursing at the moment of screening or planned pregnancy within two months after last dose
People with a diagnosis of drug or alcohol dependence syndrome will be excluded
Comorbidities or confirmed diagnoses known to cause fatigue, which may influence study outcomes, including but not limited to:
Anaemia (Hb <7.0 mmol/l for women and <8.0 mmol/l for men) and which is judged as clinically significant by the investigator
Folate deficiency (<6.0 nmol/l)
Iron deficiency (ferritin <20 g/l for women and <25 g/L for men)
Vitamin B12 deficiency (<148 pmol/l)
Liver insufficiency defined by an ALT or AST >2x ULN or total bilirubin > 2 mg/dL
Renal insufficiency defined by an estimated glomerular filtration rate < 45 mL/min, calculated using the Chronic Kidney Disease-Epidemiology Collaboration equation and/or a serum creatinine >178 μmol/L (2mg/dL)
Auto-immune disorders such as primary sclerosing cholangitis, rheumatoid ar-thritis, systemic lupus erythematosus or coeliac disease
Uncontrolled or recently diagnosed depression
Active suicidal ideation
Bipolar disorder
Schizophrenia or other psychotic disorders
Other psychiatric disorders that may interfere with the study as judged by the investigators
History or current anxiety or sleep disorders

Full record on ClinicalTrials.gov

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