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

2026年9月9日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • フェーズ2
  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • オランダ
    • Gelderland
      • Arnhem、Gelderland、オランダ、6815 AD
        • 募集
        • Rijnstate
      • Nijmegen、Gelderland、オランダ、6525GA
        • 募集
        • Radboudumc

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：プラセボ
薬：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.
アクティブコンパレータ：モダフィニル
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
The mean difference in section I of the IBD-F questionnaire at week 8
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Difference in FACIT-F questionnaire
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Change in effort sensitivity and reward sensitivity on an online effort-based decision-making task
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Radboud University Medical Center

捜査官

  • 主任研究者：Marjolijn Duijvestein, PhD, MD、Radboud University Medical Center

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年8月3日

一次修了 (推定)

2027年2月1日

研究の完了 (推定)

2027年6月1日

試験登録日

最初に提出

2026年5月6日

QC基準を満たした最初の提出物

2026年5月6日

最初の投稿 (実際)

2026年5月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月14日

QC基準を満たした最後の更新が送信されました

2026年9月9日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

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

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

all IPD that underlie results in a publication

IPD 共有時間枠

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

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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