Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial

NCT07295834 | Not Yet Recruiting Phase 2

• 3 other identifiers: 344329M-2024-2 MoultonJon Moulton Charity Trust
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Crohn's Disease; Fatigue; Ulcerative Colitis; Modafinil

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Participants randomised overall, percentage of target

  2 years

• Trial adherence

  Percentage of participants completing 12 weeks of treatment

  12 weeks

• Treatment adherence

  Percentage of participants taking at least 75% of prescribed mediation

  12 weeks

• Study procedures acceptability and compliance

  Percentage of planned data and samples collected at primary endpoint (12 weeks)

  12 weeks

• Overall acceptability

  Percentage of participants describing the treatment as acceptable (≥6/10 on 0-10 scale)

  12 weeks

Secondary Outcomes (11)

• First 5 questions of the Inflammatory Bowel Disease-Fatigue questionnaire

  12 weeks

• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale

  12 weeks

• Patient Health Questionnaire-9

  12 weeks

• Generalised Anxiety Disorder-7

  12 weeks

• Maudsley 3-item Visual Analogue Scale

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1 capsule, increasing if needed after 2 weeks to 2 capsules, increasing if needed after 2 weeks to 3 capsules. Total treatment duration 12 weeks.

Drug: Placebo

Modafinil

ACTIVE COMPARATOR

1 x 100mg, increasing if needed after 2 weeks to 2 x 100mg, increasing if needed after 2 weeks to 3 x 100mg. Total treatment duration 12 weeks.

Drug: Modafinil

Interventions

Modafinil DRUG

100-300mg daily according to patient response

Modafinil

Placebo DRUG

1-3 placebo capsules according to patient response

Placebo

Eligibility Criteria

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

You may qualify if:

• Established diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) according to clinical notes
• Reported fatigue duration of 6 months or more
• Aged 18 years or over
• Current IBD Fatigue Assessment Scale score ≥11/20
• 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.
• Faecal calprotectin \<250mcg within the last 3 months
• Normal haemoglobin concentration (≥130g/L \[men\] and ≥120g/L \[women\]) within the last 3 months
• Thyroid stimulating hormone (TSH) level (0.4-4.0 mU/L) within last 3 months
• Serum total B12 concentration (≥180 nanograms/L) within last 3 months
• Able to provide written informed consent to enter the trial.

You may not qualify if:

• Diagnosis of drug or alcohol dependence syndrome according to patient report or GP record.
• Diagnosis of any dementia according to patient report or GP record.
• Diagnosis of psychosis or schizophrenia according to patient report or GP record.
• Diagnosis of bipolar disorder according to patient report or GP record.
• Current active suicidal ideation on clinical assessment by study psychiatrist.
• 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
• Contraindications to the administration of modafinil, as per the current SmPC.
• Patient-reported hypersensitivity to modafinil
• Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held.
• Currently enrolled in another drug trial or psychological therapy trial.
• Currently hospitalised for the treatment of IBD.
• Currently being prescribed a course of budesonide or reducing course of prednisolone for IBD.
• Planned change in IBD treatment within the next 12 weeks.
• Currently breastfeeding, pregnant or planning pregnancy.
• Diagnosis of indeterminate colitis

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (4)

Imperial College Healthcare NHS Trust

London, NW10 7NS, United Kingdom

Location

St Mark's Hospital

London, NW10 7NS, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE20 7XE, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Fatigue

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; 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

• Calum Moulton

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Calum Moulton, MA MRCP MRCPsych PhD

CONTACT

+44 07384 799297; calum.moulton@nhs.net

Elena Maerz Engstler, MSc

CONTACT

elena.engstler@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 22, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)