Phase 2 Crohn's Disease and Colitis Trial, Not Yet Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who have been diagnosed with Crohn's disease or ulcerative colitis, confirmed by their medical records.
- People who have been experiencing fatigue for 6 months or longer.
- People who are 18 years of age or older.
- People whose fatigue score on the IBD Fatigue Assessment Scale is 11 out of 20 or higher.
- Women who are able to become pregnant must have a negative pregnancy test before starting the study and must agree to use an accepted form of contraception throughout the study period, such as a long-acting reversible contraceptive.
- People whose stool test result (faecal calprotectin) was below 250mcg within the last 3 months.
- People whose blood test shows a normal haemoglobin level (at least 130g/L for men, or at least 120g/L for women) within the last 3 months.
- People whose thyroid hormone level (TSH) falls within the normal range of 0.4–4.0 mU/L, tested within the last 3 months.
- People whose vitamin B12 blood level is at or above 180 nanograms/L, tested within the last 3 months.
- People who are able to give written consent to take part in the trial.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have been diagnosed with drug or alcohol dependence, based on their own report or GP records.
- People who have been diagnosed with any form of dementia, based on their own report or GP records.
- People who have been diagnosed with psychosis or schizophrenia, based on their own report or GP records.
- People who have been diagnosed with bipolar disorder, based on their own report or GP records.
- People who are currently experiencing active thoughts of suicide, as assessed by a study psychiatrist.
- People who are currently taking certain medications, including stimulants (such as methylphenidate), dopamine-related medications (such as ropinirole or L-DOPA), antipsychotics (such as olanzapine), or a specific list of other medicines including avacopan, avaritinib, bosutinib, doravirine, grazoprevir, leniosilib, moboceritinib, osimertinib, sofosbuvir, velpatasvir, or voxilaprevir.
- People for whom the study drug, modafinil, is medically unsuitable based on current prescribing guidelines (confirm with trial site).
- People who have reported an allergy or sensitivity to modafinil.
- People who are not registered with a GP, or who do not agree to allow the trial to access their GP summary care record and any psychiatric assessment records.
- People who are currently taking part in another drug trial or psychological therapy trial.
- People who are currently in hospital for the treatment of their IBD.
- People who are currently prescribed budesonide or a reducing course of prednisolone for their IBD.
- People who have a planned change to their IBD treatment within the next 12 weeks.
- People who are currently breastfeeding, pregnant, or planning to become pregnant.
- People who have been diagnosed with indeterminate colitis.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Principal Investigator: Calum Moulton, Imperial College London
Phone: +44 07384 799297
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Recruitment rate; Trial adherence; Treatment adherence; Study procedures acceptability and compliance; Overall acceptability
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.