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

Ki vehet részt

• 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

Ki nem vehet részt

• 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
• People with a diagnosis of drug or alcohol dependence syndrome will be excluded
• 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
• 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; Substance dependence disorders (e.g. alcohol, cannabis, drugs); Evidence, history, or suspicion of infectious diseases that may interfere with the study as judged by the investigators; Active Epstein-Barr virus or cytomegalovirus infection; Endocrinological disorders such as uncontrolled diabetes mellitus, untreated hy-pothyroidism, hypoadrenalism or hypogonadism; Neurological disorders such as multiple sclerosis, dementia, Parkinson's disease or myasthenia gravis; Heart failure; Chronic obstructive pulmonary disease; Obstructive sleep apnoea; Active malignancy (exception of malignancies adequately treated with resection for non-metastatic basal cell carcinoma); Long/post-COVID
• Has a clinically significant concurrent disease or relevant laboratory abnormality or a history of illness or medical condition that in the investigator's opinion could confound the study results or increase the participant's risk by taking part in the study
• 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
• Patients who are not able to complete the Dutch questionnaires in an online form