MedTrace Logo

Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial

NCT07295834 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-12-22

No results posted yet for this study

Summary

Fatigue is a big problem in people with inflammatory bowel disease (IBD). Even when IBD is well controlled, 50% of patients remain fatigued most of the time. Fatigue can be physical (e.g. feeling tired or weak) and mental (e.g. brain fog). However, there are no effective treatments for IBD fatigue.

Modafinil is a medication that can rapidly improve fatigue. It usually acts within 30 minutes and improves wakefulness. It can also improve brain fog. Modafinil has been used for over 30 years in people with narcolepsy, which is a condition where people fall asleep during the day. Modafinil has also been used in people who do not have narcolepsy.

This study will compare modafinil with a dummy tablet (placebo) in people with IBD. This is a feasibility study. This means it primarily aims to test whether a trial like this can be conducted in people with IBD.

Half of the patients in the study will receive modafinil and half will receive placebo. Treatment will be 12 weeks. Patients will start by taking 1 tablet and will then increase to 2 tablets and then 3 tablets if needed. A computer will randomly allocate treatment, meaning there is an equal chance of being allocated modafinil or placebo. They will be followed up after 6 weeks and 12 weeks.

Being a feasibility study, the investigators will measure how many patients consent to the study; how many complete treatment; and how acceptable the treatment is. Participants will complete a range of questionnaires measuring fatigue, mental health and gut health, primarily to look at the completeness and spread of data, and to obtain estimates of treatment effects and their variance.

If feasible, this study will support a larger version of the trial.

Conditions

  • Crohn Disease (CD)
  • Ulcerative Colitis (UC)
  • Fatigue

Interventions

DRUG

Modafinil

100-300mg daily according to patient response

DRUG

Placebo

1-3 placebo capsules according to patient response

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Calum Moulton · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-12-01
Completion
2028-02-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT07295834 on ClinicalTrials.gov