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

NCT07582458 | Not Yet Recruiting Phase 2

• 2 other identifiers: MODIBD6562026-525163-41-00
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Modafinil; Inflammatory bowel disease; Crohn; Colitis; Fatigue; Remission; Pharmacological

Outcome Measures

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.

  at week 8 (end of treatment)

Secondary Outcomes (9)

• Difference in FACIT-F questionnaire

  comparing baseline with week 4, 8 and 12

• Difference in section I of the IBD-F questionnaire

  comparing baseline with week 4 and week 12

• Difference in Inflammatory Bowel Disease Questionnaire (IBDQ)

  comparing baseline with week 4, 8 and 12

• Difference in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

  comparing baseline with week 8 and 12

• Difference in Pittsburgh Sleep Quality Index (PSQI)

  comparing baseline with week 8 and week 12

Other Outcomes (1)

• Change in effort sensitivity and reward sensitivity on an online effort-based decision-making task

  Baseline and week 8

Study Arms (2)

Modafinil

ACTIVE COMPARATOR

Modafinil

Drug: Modafinil

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

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.

Placebo

Modafinil DRUG

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.

Modafinil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Severe fatigue as confirmed with a score of ≥11 on section I of the IBD-F
• 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
• Faecal calprotectin \<250 µg/g
• Stable IBD medication for ≥3 months before screening visit and no change in IBD medication planned for ≥3 months

You may not qualify if:

• Contraindications for the use of modafinil, such as:
• 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
• Patients using medication which interacts clinically significant with modafinil, see section 3.3 'Mechanism of action \& Drug class'
• Patients using pharmacological agents with similar effects to modafinil, like central nerv-ous system (CNS) stimulants or other wakefulness-promoting drugs such as methylphenidate and amphetamines
• Surgery before or during study period that impacts ability to participate in this study, per investigator judgement
• Participation in another intervention study (excl. registries and post marketing studies)
• Pregnancy or nursing at the moment of screening or planned pregnancy within two months after last dose
• People with a diagnosis of drug or alcohol dependence syndrome will be excluded
• Comorbidities or confirmed diagnoses known to cause fatigue, which may influence study outcomes, including but not limited to:
• Anaemia (Hb \<7.0 mmol/l for women and \<8.0 mmol/l for men) and which is judged as clinically significant by the investigator
• Folate deficiency (\<6.0 nmol/l)
• Iron deficiency (ferritin \<20 g/l for women and \<25 g/L for men)

Sponsors & Collaborators

• Radboud University Medical Center: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Colitis; Fatigue

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Marjolijn Duijvestein, PhD, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manal Aourag, MD

CONTACT

+31640982958; Manal.aourag@radboudumc.nl

Joris Hendriks, MD

CONTACT

+31641260377; Joris.Hendriks@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years after the publication of results