Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT07295834
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07295834
Study Brief:
Protocol Section:
NCT07295834