Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRadboud University Medical Center
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Modafinil
DrugModafinil, administered orally as over-encapsulated tablets. Participants start with 100 mg once daily for the first 2 weeks. Depending on clinical response and tolerability, the dose may be increased stepwise during follow-up contacts to a maximum of 300 mg per day. Treatment duration is 8 weeks.
Placebo
DrugMatching placebo administered orally, identical in appearance, dosing frequency, and dose-adjustment schedule to modafinil in order to maintain double blinding. Treatment duration is 8 weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ModafinilActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The mean difference in section I of the IBD-F questionnaire at week 8
Fatigue severity will be assessed using section I of the Inflammatory Bowel Disease-Fatigue (IBD-F) questionnaire, a patient-reported measure of fatigue in people with inflammatory bowel disease. Section I is used to assess the severity of fatigue symptoms. Scores on section I range from 0 to 20, with higher scores indicating more severe fatigue. The outcome is the between-group difference in IBD-F section I score at week 8.
Time frame
at week 8 (end of treatment)Secondary outcomes
1
Difference in FACIT-F questionnaire
Fatigue will also be assessed using the FACIT-F questionnaire, a patient-reported measure of fatigue and its impact on daily activities and functioning. Total scores range from 0 to 52, with higher scores indicating less fatigue and better functioning. This outcome evaluates change from baseline over time.
Time frame
comparing baseline with week 4, 8 and 122
Difference in section I of the IBD-F questionnaire
Section I of the IBD-F questionnaire measures severity of fatigue symptoms in people with inflammatory bowel disease. Scores range from 0 to 20, with higher scores indicating more severe fatigue. This secondary outcome evaluates change from baseline at additional time points before and after the end of treatment.
Time frame
comparing baseline with week 4 and week 123
Difference in Inflammatory Bowel Disease Questionnaire (IBDQ)
Quality of life will be assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ), a disease-specific patient-reported measure covering bowel symptoms, emotional health, social function, and systemic symptoms. Total scores range from 32 to 224, with higher scores indicating better disease-related quality of life. This outcome evaluates change from baseline over time.
Time frame
comparing baseline with week 4, 8 and 124
Difference in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
General health status will be assessed using the EQ-5D-5L, a standardized patient-reported measure of health-related quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher index or utility values indicate better health status. This outcome evaluates change from baseline after treatment and at follow-up.
Time frame
comparing baseline with week 8 and 12Other outcomes
1
Change in effort sensitivity and reward sensitivity on an online effort-based decision-making task
Motivational behaviour will be explored using a validated online effort-based decision-making task. This task assesses how participants make choices between options that differ in required effort and potential reward. The exploratory outcome will evaluate task-based measures of effort sensitivity, reward sensitivity, and the effort-reward trade-off, to examine whether modafinil affects cognitive processes related to motivation. Higher willingness to choose high-effort options for reward may reflect lower effort sensitivity and/or greater reward sensitivity. Exact task-derived parameters will be analyzed exploratorily.
Time frame
Baseline and week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov