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Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial) (MODIFI-IBD)

2026년 9월 9일 업데이트: Radboud University Medical Center

Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease: a Multicentre,Randomised, Double-blind, Placebo-controlled, Clinical Trial (MODIFI-IBD Trial)

The goal of this clinical trial is to learn if modafinil can treat severe fatigue in adults aged 18 to 75 years with quiescent inflammatory bowel disease (IBD). The main questions it aims to answer are:

Does modafinil reduce fatigue more effectively than placebo, as measured by the mean difference in section I of the IBD-F questionnaire at week 8? Is modafinil safe and well tolerated in patients with quiescent IBD and severe fatigue?

Researchers will compare modafinil to placebo to see if modafinil improves fatigue outcomes.

Participants will:

attend one screening visit including assessment of disease activity, blood tests, stool testing, and an ECG; take modafinil or placebo for 8 weeks, starting at 100 mg daily with possible dose increases based on response and tolerability; complete online questionnaires at baseline, week 4, week 8, and week 12 about fatigue, quality of life, sleep, mood, and work productivity; be contacted regularly during the treatment period to discuss effect and side effects of the study medication; complete an online effort-based decision-making task at baseline and week 8.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is frequently associated with persistent fatigue, even during clinical remission. Fatigue is one of the most burdensome symptoms reported by patients with IBD and is associated with impaired quality of life, reduced daily functioning, and decreased work productivity. Despite its high prevalence and clinical relevance, there are currently no established pharmacological treatment options for fatigue in patients with quiescent IBD.

Modafinil is a centrally acting wakefulness-promoting agent approved for excessive daytime sleepiness in narcolepsy. It has been used for many years and has a well-characterized safety profile. Although its exact mechanism of action is not fully understood, available evidence suggests that modafinil enhances wakefulness and alertness through effects on central dopaminergic signalling. Because fatigue in IBD may involve central mechanisms related to motivation, alertness, and effort processing, modafinil is a biologically plausible candidate treatment for this population. Preliminary clinical observations have suggested that modafinil may reduce fatigue in patients with quiescent IBD, but controlled trial data are not available.

This study is a multicentre, randomized, double-blind, placebo-controlled, multicentre, clinical trial designed to evaluate the efficacy, safety, and tolerability of modafinil in adults with quiescent IBD and severe fatigue. Participants are randomized in a 1:1 ratio to receive modafinil or matching placebo. The treatment period is 8 weeks, followed by a 4-week post-treatment follow-up. To support tolerability and allow individualized treatment, study medication is started at 100 mg once daily and may be increased stepwise during follow-up contacts, based on clinical response and tolerability, up to a maximum daily dose of 300 mg. Participants assigned to placebo follow the same dosing schedule to maintain blinding.

After screening and baseline assessment, most study procedures are conducted remotely to minimize participant burden. Participants complete scheduled study assessments during treatment and follow-up and are contacted regularly by the study team to evaluate treatment response, dose adjustment, and adverse events. In addition to evaluating patient-reported outcomes related to fatigue and broader functioning, the trial includes an exploratory online effort-based decision-making task to assess motivational behaviour. Blood-based biomarker analyses will also be explored to investigate biological factors associated with fatigue and treatment response in IBD.

The placebo-controlled, double-blind design was selected because fatigue is a subjective outcome that is susceptible to placebo effects and expectation bias. This design is intended to allow a more reliable estimate of the specific treatment effect of modafinil. If modafinil is shown to be effective and well tolerated, the results of this trial may support the development of a pharmacological treatment option for an important unmet clinical need in IBD care.

연구 유형

중재적

등록 (추정된)

60

단계

  • 2 단계
  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 네덜란드
    • Gelderland
      • Arnhem, Gelderland, 네덜란드, 6815 AD
        • 모병
        • Rijnstate
      • Nijmegen, Gelderland, 네덜란드, 6525GA
        • 모병
        • Radboudumc

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Willing and able to provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study
  • Age between 18 to 75 years at screening.
  • ≥1 year diagnosis of IBD, based on a combination of clinical, endoscopic, histologic and radiologic criteria
  • Chronic fatigue for at least six months
  • Severe fatigue as confirmed with a score of ≥11 on section I of the IBD-F
  • Clinically quiescent IBD with a Harvey Bradshaw Index (HBI) <5 for CD patients or a Simple Colitis Clinical Activity Index (SCCAI) ≤2 for patients with UC or IBD-unclassified
  • Faecal calprotectin <250 µg/g
  • Stable IBD medication for ≥3 months before screening visit and no change in IBD medication planned for ≥3 months

Exclusion Criteria:

  • Contraindications for the use of modafinil, such as:

    • Uncontrolled hypertension
    • Cardiac arrhythmia
    • A history of left ventricular hypertrophy or cor pulmonale, and in patients with mitral valve prolapse who have previously developed mitral valve prolapse syn-drome during treatment with central nervous system stimulants
    • Patients with hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption
  • Patients using medication which interacts clinically significant with modafinil, see section 3.3 'Mechanism of action & Drug class'
  • Patients using pharmacological agents with similar effects to modafinil, like central nerv-ous system (CNS) stimulants or other wakefulness-promoting drugs such as methylphenidate and amphetamines
  • Surgery before or during study period that impacts ability to participate in this study, per investigator judgement
  • Participation in another intervention study (excl. registries and post marketing studies)
  • Pregnancy or nursing at the moment of screening or planned pregnancy within two months after last dose
  • People with a diagnosis of drug or alcohol dependence syndrome will be excluded

  • Comorbidities or confirmed diagnoses known to cause fatigue, which may influence study outcomes, including but not limited to:

    • Anaemia (Hb <7.0 mmol/l for women and <8.0 mmol/l for men) and which is judged as clinically significant by the investigator
    • Folate deficiency (<6.0 nmol/l)
    • Iron deficiency (ferritin <20 g/l for women and <25 g/L for men)
    • Vitamin B12 deficiency (<148 pmol/l)
    • Liver insufficiency defined by an ALT or AST >2x ULN or total bilirubin > 2 mg/dL
    • Renal insufficiency defined by an estimated glomerular filtration rate < 45 mL/min, calculated using the Chronic Kidney Disease-Epidemiology Collaboration equation and/or a serum creatinine >178 μmol/L (2mg/dL)
    • Auto-immune disorders such as primary sclerosing cholangitis, rheumatoid ar-thritis, systemic lupus erythematosus or coeliac disease
    • Uncontrolled or recently diagnosed depression
    • Active suicidal ideation
    • Bipolar disorder
    • Schizophrenia or other psychotic disorders
    • Other psychiatric disorders that may interfere with the study as judged by the investigators
    • History or current anxiety or sleep disorders
    • Substance dependence disorders (e.g. alcohol, cannabis, drugs)
    • Evidence, history, or suspicion of infectious diseases that may interfere with the study as judged by the investigators
    • Active Epstein-Barr virus or cytomegalovirus infection
    • Endocrinological disorders such as uncontrolled diabetes mellitus, untreated hy-pothyroidism, hypoadrenalism or hypogonadism
    • Neurological disorders such as multiple sclerosis, dementia, Parkinson's disease or myasthenia gravis
    • Heart failure
    • Chronic obstructive pulmonary disease
    • Obstructive sleep apnoea
    • Active malignancy (exception of malignancies adequately treated with resection for non-metastatic basal cell carcinoma)
    • Long/post-COVID
  • Patients who are not able to complete the Dutch questionnaires in an online form
  • Has a clinically significant concurrent disease or relevant laboratory abnormality or a history of illness or medical condition that in the investigator's opinion could confound the study results or increase the participant's risk by taking part in the study

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약
의약품: Placebo
Matching placebo administered orally, identical in appearance, dosing frequency, and dose-adjustment schedule to modafinil in order to maintain double blinding. Treatment duration is 8 weeks.
활성 비교기: 모다피닐
의약품: Modafinil
Modafinil, administered orally as over-encapsulated tablets. Participants start with 100 mg once daily for the first 2 weeks. Depending on clinical response and tolerability, the dose may be increased stepwise during follow-up contacts to a maximum of 300 mg per day. Treatment duration is 8 weeks.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The mean difference in section I of the IBD-F questionnaire at week 8
기간: at week 8 (end of treatment)
Fatigue severity will be assessed using section I of the Inflammatory Bowel Disease-Fatigue (IBD-F) questionnaire, a patient-reported measure of fatigue in people with inflammatory bowel disease. Section I is used to assess the severity of fatigue symptoms. Scores on section I range from 0 to 20, with higher scores indicating more severe fatigue. The outcome is the between-group difference in IBD-F section I score at week 8.
at week 8 (end of treatment)

2차 결과 측정

결과 측정
측정값 설명
기간
Difference in FACIT-F questionnaire
기간: comparing baseline with week 4, 8 and 12
Fatigue will also be assessed using the FACIT-F questionnaire, a patient-reported measure of fatigue and its impact on daily activities and functioning. Total scores range from 0 to 52, with higher scores indicating less fatigue and better functioning. This outcome evaluates change from baseline over time.
comparing baseline with week 4, 8 and 12
Difference in section I of the IBD-F questionnaire
기간: comparing baseline with week 4 and week 12
Section I of the IBD-F questionnaire measures severity of fatigue symptoms in people with inflammatory bowel disease. Scores range from 0 to 20, with higher scores indicating more severe fatigue. This secondary outcome evaluates change from baseline at additional time points before and after the end of treatment.
comparing baseline with week 4 and week 12
Difference in Inflammatory Bowel Disease Questionnaire (IBDQ)
기간: comparing baseline with week 4, 8 and 12
Quality of life will be assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ), a disease-specific patient-reported measure covering bowel symptoms, emotional health, social function, and systemic symptoms. Total scores range from 32 to 224, with higher scores indicating better disease-related quality of life. This outcome evaluates change from baseline over time.
comparing baseline with week 4, 8 and 12
Difference in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
기간: comparing baseline with week 8 and 12
General health status will be assessed using the EQ-5D-5L, a standardized patient-reported measure of health-related quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher index or utility values indicate better health status. This outcome evaluates change from baseline after treatment and at follow-up.
comparing baseline with week 8 and 12
Difference in Pittsburgh Sleep Quality Index (PSQI)
기간: comparing baseline with week 8 and week 12
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a patient-reported questionnaire that measures sleep quality and sleep disturbance. Total scores range from 0 to 21, with higher scores indicating worse sleep quality. This outcome evaluates change from baseline after treatment and at follow-up.
comparing baseline with week 8 and week 12
Difference in the Patient Health Questionnaire (PHQ-9)
기간: baseline with week 4, 8 and 12
Depressive symptoms will be assessed using the PHQ-9, a patient-reported questionnaire for the severity of depressive symptoms. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. This outcome evaluates change from baseline over time.
baseline with week 4, 8 and 12
Difference in the Generalized Anxiety Disorder Questionnaire-7 (GAD-7)
기간: baseline with week 4, 8 and 12
Anxiety symptoms will be assessed using the GAD-7, a patient-reported questionnaire for the severity of generalized anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. This outcome evaluates change from baseline over time.
baseline with week 4, 8 and 12
Difference in the IMTA Productivity Cost Questionnaire (iPCQ)
기간: baseline with week 8 and week 12
Productivity loss in paid work will be assessed using the IMTA Productivity Cost Questionnaire (iPCQ), a patient-reported measure of absenteeism, presenteeism, and reduced productivity related to health problems. Higher impairment values indicate greater productivity loss. This outcome evaluates change from baseline after treatment and at follow-up.
baseline with week 8 and week 12
The incidence of treatment-emergent adverse events, serious adverse events, events of clinical interest and adverse events that lead to discontinuation of modafinil use
기간: until 30 days post end of treatment
Safety and tolerability will be assessed by recording adverse events reported during the study. Treatment-emergent adverse events are defined as adverse events occurring or worsening after the start of study treatment. Serious adverse events, events of clinical interest, and adverse events leading to permanent discontinuation of study treatment will be summarized by treatment group.
until 30 days post end of treatment

기타 결과 측정

결과 측정
측정값 설명
기간
Change in effort sensitivity and reward sensitivity on an online effort-based decision-making task
기간: Baseline and week 8
Motivational behaviour will be explored using a validated online effort-based decision-making task. This task assesses how participants make choices between options that differ in required effort and potential reward. The exploratory outcome will evaluate task-based measures of effort sensitivity, reward sensitivity, and the effort-reward trade-off, to examine whether modafinil affects cognitive processes related to motivation. Higher willingness to choose high-effort options for reward may reflect lower effort sensitivity and/or greater reward sensitivity. Exact task-derived parameters will be analyzed exploratorily.
Baseline and week 8

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Radboud University Medical Center

수사관

  • 수석 연구원: Marjolijn Duijvestein, PhD, MD, Radboud University Medical Center

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 3일

기본 완료 (추정된)

2027년 2월 1일

연구 완료 (추정된)

2027년 6월 1일

연구 등록 날짜

최초 제출

2026년 5월 6일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 9일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • MODIBD656
  • 2026-525163-41-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

all IPD that underlie results in a publication

IPD 공유 기간

Beginning 3 months and ending 3 years after the publication of results

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다