NCT07295834Toborzás még nem indult2. fázis
Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial
A Multi-centre, Double-blind Randomised Controlled Trial to Compare Modafinil Versus Placebo Over 12 Weeks in Patients With Severe Fatigue and Inflammatory Bowel Disease (MFI): a Feasibility Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 22.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 70 (tervezett)
- Első benyújtás
- 2025. nov. 20.
- Kezdés
- 2026. febr. 1.
- Elsődleges befejezés
- 2027. dec. 1.
- Fő szponzor
- Imperial College London
- Betegségek
- Crohn-betegség, Colitis ulcerosa
- NCT-szám
- NCT07295834
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 70
- 2026. febr. 1. és az elsődleges befejezés (2027. dec. 1.) között
- 4 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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
- Currently enrolled in another drug trial or psychological therapy trial.
Más betegség
- 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 bipolar disorder according to patient report or GP record.
- 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.
Egyéb
- Diagnosis of psychosis or schizophrenia according to patient report or GP record.
- Current active suicidal ideation on clinical assessment by study psychiatrist.
- Contraindications to the administration of modafinil, as per the current SmPC.
- 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
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (4)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| St Mark's Hospital | London | Egyesült Királyság | Ismeretlen állapot |
| Guy's and St Thomas' NHS Foundation Trust | London | Egyesült Királyság | Ismeretlen állapot |
| King's College Hospital NHS Foundation Trust | London | Egyesült Királyság | Ismeretlen állapot |
| Imperial College Healthcare NHS Trust | London | Egyesült Királyság | Ismeretlen állapot |
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