Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial)
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- Modafinil
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov