Modafinil for Inflammatory bowel disease | Fatigue

Inclusion criteria

• {"criterion_text":"- Patient is able and willing to provide written informed consent"}
• {"criterion_text":"- Age between 18 to 75 years at screening≥1 year diagnosis of IBD, based on a combination of clinical, endoscopic, histologic and radiologic criteria"}
• {"criterion_text":"- Chronic fatigue for at least 6 months"}
• {"criterion_text":"- Severe fatigue as confirmed with a score of ≥11 on section I of the IBD-F"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Fecal calprotectin <150 µg/g"}
• {"criterion_text":"- Stable IBD medication (or absence of IBD medication) for ≥3 months before randomization and no change in IBD medication planned for ≥3 months"}

Exclusion criteria

• {"criterion_text":"- Contraindications for the use of modafinil, such as but not limited to uncontrolled hypertension and cardiac arrhythmia"}
• {"criterion_text":"- Patients using medication which interacts clinically significant with modafinil"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Participation in another intervention study (excl. registries and post marketing studies)"}
• {"criterion_text":"- Pregnant at the moment of the screening visit or planning pregnancy within 2 months after last dose"}
• {"criterion_text":"- Planned surgery before or during study period that impacts ability to participate in this study, per investigator judgement"}
• {"criterion_text":"- Confirmed diagnosis of other potential causes of fatigue, such as anaemia, specific vitamin deficiencies as well as somatic or psychiatric comorbidities"}

Primary endpoints

• {"endpoint_text":"- The mean difference in section I of the IBD-F questionnaire at week 8","definition_or_measurement_approach":"Mean difference in section I score of the IBD-F questionnaire measured at week 8 comparing modafinil versus placebo"}

Secondary endpoints

• {"endpoint_text":"- Difference in Inflammatory Bowel Disease Questionnaire (IBDQ) comparing baseline with week 4, 8 and 12","definition_or_measurement_approach":"Change from baseline in IBDQ at weeks 4, 8 and 12"}
• {"endpoint_text":"- Difference in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) comparing baseline with week 8 and 12","definition_or_measurement_approach":"Change from baseline in EQ-5D-5L at weeks 8 and 12"}
• {"endpoint_text":"- Difference in Pittsburgh Sleep Quality Index (PSQI) comparing baseline with week 8 and week","definition_or_measurement_approach":"Change from baseline in PSQI at week 8 and week 12"}
• {"endpoint_text":"- Difference in the Patient Health Questionnaire (PHQ-9) comparing baseline with week 4, 8 and 12","definition_or_measurement_approach":"Change from baseline in PHQ-9 at weeks 4, 8 and 12"}
• {"endpoint_text":"- Difference in the Generalized Anxiety Disorder Questionnaire-7 (GAD-7) comparing baseline with week 4, 8 and 12","definition_or_measurement_approach":"Change from baseline in GAD-7 at weeks 4, 8 and 12"}
• {"endpoint_text":"- Difference in the IMTA Productivity Cost Questionnaire (iPCQ) comparing baseline with week 8 and week 12","definition_or_measurement_approach":"Change from baseline in iPCQ at weeks 8 and 12"}
• {"endpoint_text":"- The incidence of treatment-emergent adverse events, serious adverse events, events of clinical interest and adverse events that lead to discontinuation of modafinil use until 30 days post end of treatment","definition_or_measurement_approach":"Incidence and classification of treatment-emergent AEs, SAEs and events of clinical interest up to 30 days after end of treatment"}
• {"endpoint_text":"- To evaluate the effect of modafinil on cognitive processes related to motivation, an exploratory endpoint will assess effort sensitivity and reward sensitivity using a validated online effort-based decision-making task","definition_or_measurement_approach":"Assessment of effort sensitivity and reward sensitivity using a validated online effort-based decision-making task"}
• {"endpoint_text":"- To explore the association between blood based biomarkers and their ability to identify fatigue in IBD","definition_or_measurement_approach":"Exploratory association analyses between blood biomarkers and fatigue measures"}
• {"endpoint_text":"- Difference in FACIT-F questionnaire comparing baseline with week 4, 8 and 12","definition_or_measurement_approach":"Change from baseline in FACIT-F at weeks 4, 8 and 12"}
• {"endpoint_text":"- Difference in section I of the IBD-F questionnaire comparing baseline with week 4 and week 12","definition_or_measurement_approach":"Change from baseline in section I of the IBD-F at weeks 4 and 12"}

Other endpoints

• {"endpoint_text":"- To evaluate the effect of modafinil on cognitive processes related to motivation, an exploratory endpoint will assess effort sensitivity and reward sensitivity using a validated online effort-based decision-making task","definition_or_measurement_approach":"Exploratory online effort-based decision-making task assessing effort sensitivity and reward sensitivity"}
• {"endpoint_text":"- To explore the association between blood based biomarkers and their ability to identify fatigue in IBD","definition_or_measurement_approach":"Exploratory analyses of blood-based biomarkers and their association with fatigue measures"}

Netherlands

Earliest CTIS Part Ii Submission Date

17-04-2026

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

17

Number Of Sites

6

Number Of Participants

60

Primary sponsor

Full Name

Radboud universitair medisch centrum Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands