ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Fatigue is a common, disabling symptom in people with quiescent IBD and currently lacks approved pharmacological treatments. This trial tests whether modafinil can safely reduce fatigue and improve daily functioning for adults with Crohn’s disease or ulcerative colitis in remission.
Who Should Pay Attention
Adults with IBD experiencing persistent fatigue, IBD clinicians, and researchers focused on fatigue or QoL interventions.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 2, Phase 3
Enrollment60 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a registered, randomized, double‑blind, placebo‑controlled Phase 2/3 trial testing modafinil versus placebo for severe fatigue in adults (18–75) with quiescent IBD (Crohn’s disease or ulcerative colitis).
Treatment lasts 8 weeks with a flexible dose starting at 100 mg/day and possible increases to 300 mg/day; primary outcome is change in section I of the IBD‑F fatigue questionnaire at week 8. Most procedures are conducted remotely; safety monitoring includes blood and stool tests and an ECG.
The trial will also collect exploratory blood biomarkers and an online effort‑based decision task to study motivation. If positive, this study could provide the first controlled pharmacologic data on treating fatigue in quiescent IBD, a common and burdensome symptom without established drug treatments.
Keep In Mind
This is a trial record (Phase 2/3, randomized, placebo‑controlled) and does not provide study results. Modafinil is approved for sleep disorders but not for IBD fatigue; safety and efficacy in this indication are being evaluated.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorRadboud University Medical Center
Trial IDNCT07582458
Study typeInterventional
Trial phasePhase 2, Phase 3
Enrollment60 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedSep 14, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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