Phase 3 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 are willing and able to sign a consent form at the screening visit and attend all required study visits until the end of the trial
- People aged between 18 and 75 years at the time of screening
- People who have had a confirmed diagnosis of inflammatory bowel disease (IBD) for at least 1 year, based on a combination of clinical tests, camera examinations, tissue samples, and imaging
- People who have been experiencing ongoing tiredness for at least 6 months
- People with severe fatigue, confirmed by a score of 11 or higher on a specific section of a fatigue questionnaire used in IBD (called the IBD-F)
- People whose IBD is currently in a stable, low-activity state, confirmed by scoring below certain thresholds on standard disease activity measures used by doctors (specific to the type of IBD diagnosed)
- People with a stool test result (faecal calprotectin) below 250 µg/g, indicating low gut inflammation
- People whose IBD medications have stayed the same for at least 3 months before screening, with no planned changes for at least 3 months after
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 medical reasons why they cannot take the study drug modafinil, including:
- People with uncontrolled high blood pressure
- People with an irregular heartbeat
- People with a history of a thickened left heart wall, a certain type of heart-lung condition, or a specific heart valve condition that previously caused problems when taking stimulant medications
- People with certain inherited conditions affecting how the body processes a type of sugar (galactose-related disorders) (confirm with trial site)
- People taking other medications that are known to interact significantly with the study drug modafinil (confirm with trial site)
- People currently using medications with similar effects to modafinil, such as stimulant drugs or other wakefulness-promoting medicines like methylphenidate or amphetamines
- People who have had or are planning surgery during the study period that would affect their ability to take part, as judged by the study doctor
- People currently participating in another interventional research study (not including registries or post-marketing studies)
- People who are pregnant, breastfeeding, or planning to become pregnant within two months after the last dose of the study drug
- People with a diagnosis of drug or alcohol dependence
- People with other health conditions or confirmed diagnoses known to cause fatigue that could affect study results, including:
- Low red blood cell levels (anaemia) judged to be clinically significant by the study doctor
- Low folate levels
- Low iron levels (based on ferritin blood test results)
- Low vitamin B12 levels
- Poor liver function, shown by certain abnormal blood test results
- Poor kidney function, shown by certain abnormal blood test results
- Autoimmune conditions such as primary sclerosing cholangitis, rheumatoid arthritis, lupus, or coeliac disease
- Uncontrolled or recently diagnosed depression
- Active thoughts of suicide
- Bipolar disorder
- Schizophrenia or other psychotic conditions
- Other psychiatric conditions that the study doctors consider may interfere with the study
- A current or past history of anxiety or sleep disorders
- Substance dependence (for example, alcohol, cannabis, or other drugs)
- Evidence, history, or suspicion of infectious diseases that may interfere with the study, as judged by the study doctors
- An active Epstein-Barr virus or cytomegalovirus infection
- Hormonal or gland-related conditions such as uncontrolled diabetes, untreated underactive thyroid, or certain adrenal or hormone deficiencies
- Neurological conditions such as multiple sclerosis, dementia, Parkinson's disease, or myasthenia gravis
- Heart failure
- Chronic obstructive pulmonary disease (a long-term lung condition)
- Obstructive sleep apnoea
- An active cancer (with the exception of certain non-spreading skin cancers that have been fully removed)
- Long COVID or post-COVID condition
- People who are not able to complete Dutch-language questionnaires in an online format
- People with other significant health conditions, abnormal test results, or medical histories that the study doctors believe could affect the study results or increase the risks of taking part
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: Marjolijn Duijvestein, PhD, MD, Radboud University Medical Center
Phone: +31640982958
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
Primary endpoints
The mean difference in section I of the IBD-F questionnaire at week 8
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.