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

NCT07582458 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
  • Chronic Fatigue

Interventions

DRUG

Modafinil

Modafinil, 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.

DRUG

Placebo

Matching 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.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Marjolijn Duijvestein, PhD, MD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-02-01
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07582458 on ClinicalTrials.gov