2026-525163-41-00招募中3 期
Modafinil for debilitating fatigue in quiescent inflammatory bowel disease: a multicentre, randomised, double-blind, placebo-controlled, clinical trial (MODIFI-IBD trial)
Radboud universitair medisch centrum Stichting8 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- The mean difference in section I of the IBD-F questionnaire at week 8
研究概览
简要总结
To investigate efficacy of modafinil versus placebo for the treatment of severe fatigue in patients with quiescent IBD
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient is able and willing to provide written informed consent
- •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 6 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
- •Fecal calprotectin <150 µg/g
- •Stable IBD medication (or absence of IBD medication) for ≥3 months before randomization and no change in IBD medication planned for ≥3 months
排除标准
- •Contraindications for the use of modafinil, such as but not limited to uncontrolled hypertension and cardiac arrhythmia
- •Patients using medication which interacts clinically significant with modafinil
- •Patients using pharmacological agents with similar effects to modafinil, like central nervous system (CNS) stimulants or other wakefulness-promoting drugs such as methylphenidate and amphetamines
- •Participation in another intervention study (excl. registries and post marketing studies)
- •Pregnant at the moment of the screening visit or planning pregnancy within 2 months after last dose
- •Planned surgery before or during study period that impacts ability to participate in this study, per investigator judgement
- •Confirmed diagnosis of other potential causes of fatigue, such as anaemia, specific vitamin deficiencies as well as somatic or psychiatric comorbidities
研究组 & 干预措施
Modiodal 100 mg tabletten
Test
干预措施: Modiodal 100 mg tabletten (Drug)
PLACEBO
Placebo
干预措施: PLACEBO (Drug)
结局指标
主要结局
The mean difference in section I of the IBD-F questionnaire at week 8
The mean difference in section I of the IBD-F questionnaire at week 8
次要结局
- Difference in Inflammatory Bowel Disease Questionnaire (IBDQ) comparing baseline with week 4, 8 and 12
- Difference in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) comparing baseline with week 8 and 12
- Difference in Pittsburgh Sleep Quality Index (PSQI) comparing baseline with week 8 and week
- Difference in the Patient Health Questionnaire (PHQ-9) comparing baseline with week 4, 8 and 12
- Difference in the Generalized Anxiety Disorder Questionnaire-7 (GAD-7) comparing baseline with week 4, 8 and 12
- Difference in the IMTA Productivity Cost Questionnaire (iPCQ) comparing 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 until 30 days post end of treatment
- To evaluate the effect of modafinil on cognitive processes related to motivation, an exploratory endpoint will assess effort sensitivity and reward sensitivity using a validated online effort-based decision-making task
- To explore the association between blood based biomarkers and their ability to identify fatigue in IBD
- Difference in FACIT-F questionnaire comparing baseline with week 4, 8 and 12
- Difference in section I of the IBD-F questionnaire comparing baseline with week 4 and week 12
研究者
Marjolijn Duijvestein
Scientific
Radboud universitair medisch centrum Stichting
研究点 (8)
Loading locations...
相似试验
招募中
4 期
Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LEBV® and 2LXFS® on asthenia in patients with an EBV infection2024-514222-24-00Labo'Life Belgium, Labo'Life Belgium88
尚未招募
3 期
Effect of Zincovit ACTIVE Instant Rehydration Solution in fatigue and stressCTRI/2024/05/067877Apex Laboratories Private Limited80
已完成
不适用
Reducing fatigue, depression, and cognitive deficits with modafinil in low-grade glioma patients.fatigue, depression, cognition in low-grade glioma patientsNL-OMON25601Department of neurologyVU University Medical CenterP.O. Box 70571007 MB Amsterdam64
已完成
3 期
Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)Breast CancerProstatic NeoplasmsNCT00917748Sanofi84
已完成
不适用
Modafinil for the treatment of fatigue in lung cancer: a pilot studyon small cell lung cancerNon small cell lung cancerCancerISRCTN82265570Cambridge University Hospitals NHS Foundation Trust (UK)208