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Could a narcolepsy drug beat IBD fatigue?

NCT ID NCT07295834

Symptom relief Sponsor: Imperial College London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether modafinil, a drug used for narcolepsy, can reduce severe fatigue in people with Crohn's disease or ulcerative colitis. About 70 participants will receive either modafinil or a placebo for 12 weeks. The main goal is to see if a larger trial is possible, but researchers will also measure changes in fatigue and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
modafinil
What this could lead to
If this works, it could point toward a new treatment for severe fatigue in people with inflammatory bowel disease.
What could go wrong
This is a small, early feasibility study, not a large confirmatory trial. It may not show clear benefit, and modafinil can cause side effects like headache or anxiety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Established diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) according to clinical notes 2. Reported fatigue duration of 6 months or more 3. Aged 18 years or over 4. Current IBD Fatigue Assessment Scale score ≥11/20 5. Use of contraception if female and of childbearing age. Female participants of childbearing age will require a negative serum/urine pregnancy test before starting the study and will also need to agree to use an acceptable form of contraception throughout the intervention period, e.g. long-acting reversible contraceptive. 6. Faecal calprotectin \<250mcg within the last 3 months 7. Normal haemoglobin concentration (≥130g/L \[men\] and ≥120g/L \[women\]) within the last 3 months 8. Thyroid stimulating hormone (TSH) level (0.4-4.0 mU/L) within last 3 months 9. Serum total B12 concentration (≥180 nanograms/L) within last 3 months 10. Able to provide written informed consent to enter the trial. Exclusion Criteria: 1. Diagnosis of drug or alcohol dependence syndrome according to patient report or GP record. 2. Diagnosis of any dementia according to patient report or GP record. 3. Diagnosis of psychosis or schizophrenia according to patient report or GP record. 4. Diagnosis of bipolar disorder according to patient report or GP record. 5. Current active suicidal ideation on clinical assessment by study psychiatrist. 6. Current treatment with stimulant medication (e.g. methylphenidate), dopamine agonist (e.g. ropinirole), levo-dopa (L-DOPA), antipsychotic (e.g. olanzapine), avacopan, avaritinib, bosutinib, doravirine, grazoprevir, leniosilib, moboceritinib, Osimertinib, sofosbuvir, velpatasvir or voxilapravir 7. Contraindications to the administration of modafinil, as per the current SmPC. 8. Patient-reported hypersensitivity to modafinil 9. Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held. 10. Currently enrolled in another drug trial or psychological therapy trial. 11. Currently hospitalised for the treatment of IBD. 12. Currently being prescribed a course of budesonide or reducing course of prednisolone for IBD. 13. Planned change in IBD treatment within the next 12 weeks. 14. Currently breastfeeding, pregnant or planning pregnancy. 15. Diagnosis of indeterminate colitis

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Conditions

The condition(s) this trial relates to.

Crohn disease Fatigue ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease (CD) Fatigue Ulcerative colitis (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT, United Kingdom

  • Imperial College Healthcare NHS Trust

    London, NW10 7NS, United Kingdom

  • King's College Hospital NHS Foundation Trust

    London, SE20 7XE, United Kingdom

  • St Mark's Hospital

    London, NW10 7NS, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.