A clinical study investigating modafinil for the treatment of severe fatigue in patients with inflammatory bowel disease (MODIFI-IBD trial)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Radboud universitair medisch centrum Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2026-05-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To investigate efficacy of modafinil versus placebo for the treatment of severe fatigue in patients with quiescent IBD

Secondary objectives 6

1. To evaluate the effect of modafinil versus placebo on the difference in quality of life of participants with quiescent IBD and severe fatigue
2. To evaluate the effect of modafinil versus placebo on the difference in sleep quality of participants with quiescent IBD and severe fatigue
3. To evaluate the effect of modafinil versus placebo on the difference in depression and anxiety symptoms of participants with quiescent IBD and severe fatigue
4. To evaluate the effect of modafinil versus placebo on the difference in productivity loss in (paid) work of participants with quiescent IBD and severe fatigue
5. To evaluate safety and tolerability of modafinil versus placebo in participants with quiescent IBD and severe fatigue
6. To investigate efficacy of modafinil versus placebo for the treatment of severe fatigue in participants with quiescent IBD

Conditions and MedDRA coding

Inflammatory bowel disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patient is able and willing to provide written informed consent
2. Age between 18 to 75 years at screening≥1 year diagnosis of IBD, based on a combination of clinical, endoscopic, histologic and radiologic criteria
3. Chronic fatigue for at least 6 months
4. Severe fatigue as confirmed with a score of ≥11 on section I of the IBD-F
5. 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
6. Fecal calprotectin <150 µg/g
7. Stable IBD medication (or absence of IBD medication) for ≥3 months before randomization and no change in IBD medication planned for ≥3 months

Exclusion criteria 7

1. Contraindications for the use of modafinil, such as but not limited to uncontrolled hypertension and cardiac arrhythmia
2. Patients using medication which interacts clinically significant with modafinil
3. Patients using pharmacological agents with similar effects to modafinil, like central nervous system (CNS) stimulants or other wakefulness-promoting drugs such as methylphenidate and amphetamines
4. Participation in another intervention study (excl. registries and post marketing studies)
5. Pregnant at the moment of the screening visit or planning pregnancy within 2 months after last dose
6. Planned surgery before or during study period that impacts ability to participate in this study, per investigator judgement
7. Confirmed diagnosis of other potential causes of fatigue, such as anaemia, specific vitamin deficiencies as well as somatic or psychiatric comorbidities

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The mean difference in section I of the IBD-F questionnaire at week 8

Secondary endpoints 11

1. Difference in Inflammatory Bowel Disease Questionnaire (IBDQ) comparing baseline with week 4, 8 and 12
2. Difference in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) comparing baseline with week 8 and 12
3. Difference in Pittsburgh Sleep Quality Index (PSQI) comparing baseline with week 8 and week
4. Difference in the Patient Health Questionnaire (PHQ-9) comparing baseline with week 4, 8 and 12
5. Difference in the Generalized Anxiety Disorder Questionnaire-7 (GAD-7) comparing baseline with week 4, 8 and 12
6. Difference in the IMTA Productivity Cost Questionnaire (iPCQ) comparing baseline with week 8 and week 12
7. The incidence of treatment-emergent adverse events, serious adverse events, events of clinical interest and adverse events that lead to discontinuation of modafinil use until 30 days post end of treatment
8. To evaluate the effect of modafinil on cognitive processes related to motivation, an exploratory endpoint will assess effort sensitivity and reward sensitivity using a validated online effort-based decision-making task
9. To explore the association between blood based biomarkers and their ability to identify fatigue in IBD
10. Difference in FACIT-F questionnaire comparing baseline with week 4, 8 and 12
11. Difference in section I of the IBD-F questionnaire comparing baseline with week 4 and week 12

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Radboud universitair medisch centrum Stichting

Sponsor organisation

Radboud universitair medisch centrum Stichting

Address

Geert Grooteplein Zuid 10

City

Nijmegen

Postcode

6525 GA

Country

Netherlands

Scientific contact point

Organisation

Radboud universitair medisch centrum Stichting

Contact name

Marjolijn Duijvestein

Public contact point

Organisation

Radboud universitair medisch centrum Stichting

Contact name

Marjolijn Duijvestein

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications