A Multi-centre, Double-blind Randomised Controlled Trial to Compare Modafinil Versus Placebo Over 12 Weeks in Patients With Severe Fatigue and Inflammatory Bowel Disease (MFI): a Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Recruitment rate
研究概览
简要总结
Fatigue is a big problem in people with inflammatory bowel disease (IBD). Even when IBD is well controlled, 50% of patients remain fatigued most of the time. Fatigue can be physical (e.g. feeling tired or weak) and mental (e.g. brain fog). However, there are no effective treatments for IBD fatigue.
Modafinil is a medication that can rapidly improve fatigue. It usually acts within 30 minutes and improves wakefulness. It can also improve brain fog. Modafinil has been used for over 30 years in people with narcolepsy, which is a condition where people fall asleep during the day. Modafinil has also been used in people who do not have narcolepsy.
This study will compare modafinil with a dummy tablet (placebo) in people with IBD. This is a feasibility study. This means it primarily aims to test whether a trial like this can be conducted in people with IBD.
Half of the patients in the study will receive modafinil and half will receive placebo. Treatment will be 12 weeks. Patients will start by taking 1 tablet and will then increase to 2 tablets and then 3 tablets if needed. A computer will randomly allocate treatment, meaning there is an equal chance of being allocated modafinil or placebo. They will be followed up after 6 weeks and 12 weeks.
Being a feasibility study, the investigators will measure how many patients consent to the study; how many complete treatment; and how acceptable the treatment is. Participants will complete a range of questionnaires measuring fatigue, mental health and gut health, primarily to look at the completeness and spread of data, and to obtain estimates of treatment effects and their variance.
If feasible, this study will support a larger version of the trial.
详细描述
Design: The current study is a randomised controlled trial (a study in which people are allocated by chance to receive different interventions). The trial will compare mirtazapine against a placebo (dummy) tablet in 70 patients with both severe fatigue and IBD. This is a feasibility study, meaning that it is testing whether it will be possible to do a larger version of this study.
Setting: Consent and assessments will take placebo in clinic rooms or clinical research facilities at Imperial College Healthcare National Health Service (NHS) Foundation Trust, King's College Hospital, St Mark's Hospital and Guy's and St Thomas' Hospital, or online if the patient prefers this. The latter is important in maximising participation to the study for participants who may find it difficult to access hospitals, which is a common problem in inflammatory bowel disease (IBD) due to issues like pain and incontinence.
Recruitment: Consecutive patients aged ≥18 with diagnosed IBD and significant fatigue will be identified from outpatient clinics and biologics infusion suites. If possible, clinicians will use the IBD Fatigue Scale to identify people scoring ≥11. If necessary, patients will be identified from screening of endoscopy schedules and IBD multidisciplinary team meetings. The clinical team will seek the patient's permission to be contacted by the research team.
If they agree, the research team will then contact the patient - either in the clinic or over the phone - and provide the patient information sheet. The research team will check some basic pre-screening questions: confirming IBD diagnosis, duration of fatigue, whether they are planned to change any IBD treatments in the next 12 weeks, and the 5- question IBD Fatigue Assessment Scale if not already completed. Before pre-screening, the research team will advise patients that the fatigue information they provide will be passed onto their clinical team - with their permission - even if they decide not to take part in the study. They will be advised that any other information about their IBD will not be retained by the study team if they do not wish to take part. If anyone has an elevated fatigue score but does not wish to take part in the study, the research team will seek the patient's permission to relay the fatigue score to their clinical team.
Those who are deemed to be potentially eligible after pre-screening will be invited for a full screening assessment with a member of the study team. Final study inclusion and consent will be taken by a study doctor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) according to clinical notes
- •Reported fatigue duration of 6 months or more
- •Aged 18 years or over
- •Current IBD Fatigue Assessment Scale score ≥11/20
- •Use of contraception if female and of childbearing age. Female participants of childbearing age will require a negative serum/urine pregnancy test before starting the study and will also need to agree to use an acceptable form of contraception throughout the intervention period, e.g. long-acting reversible contraceptive.
- •Faecal calprotectin <250mcg within the last 3 months
- •Normal haemoglobin concentration (≥130g/L [men] and ≥120g/L [women]) within the last 3 months
- •Thyroid stimulating hormone (TSH) level (0.4-4.0 mU/L) within last 3 months
- •Serum total B12 concentration (≥180 nanograms/L) within last 3 months
- •Able to provide written informed consent to enter the trial.
排除标准
- •Diagnosis of drug or alcohol dependence syndrome according to patient report or GP record.
- •Diagnosis of any dementia according to patient report or GP record.
- •Diagnosis of psychosis or schizophrenia according to patient report or GP record.
- •Diagnosis of bipolar disorder according to patient report or GP record.
- •Current active suicidal ideation on clinical assessment by study psychiatrist.
- •Current treatment with stimulant medication (e.g. methylphenidate), dopamine agonist (e.g. ropinirole), levo-dopa (L-DOPA), antipsychotic (e.g. olanzapine), avacopan, avaritinib, bosutinib, doravirine, grazoprevir, leniosilib, moboceritinib, Osimertinib, sofosbuvir, velpatasvir or voxilapravir
- •Contraindications to the administration of modafinil, as per the current SmPC.
- •Patient-reported hypersensitivity to modafinil
- •Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held.
- •Currently enrolled in another drug trial or psychological therapy trial.
- •Currently hospitalised for the treatment of IBD.
- •Currently being prescribed a course of budesonide or reducing course of prednisolone for IBD.
- •Planned change in IBD treatment within the next 12 weeks.
- •Currently breastfeeding, pregnant or planning pregnancy.
- •Diagnosis of indeterminate colitis
研究组 & 干预措施
Placebo
1 capsule, increasing if needed after 2 weeks to 2 capsules, increasing if needed after 2 weeks to 3 capsules. Total treatment duration 12 weeks.
干预措施: Placebo (Drug)
Modafinil
1 x 100mg, increasing if needed after 2 weeks to 2 x 100mg, increasing if needed after 2 weeks to 3 x 100mg. Total treatment duration 12 weeks.
干预措施: Modafinil (Drug)
结局指标
主要结局
Recruitment rate
时间窗: 2 years
Participants randomised overall, percentage of target
Trial adherence
时间窗: 12 weeks
Percentage of participants completing 12 weeks of treatment
Treatment adherence
时间窗: 12 weeks
Percentage of participants taking at least 75% of prescribed mediation
Study procedures acceptability and compliance
时间窗: 12 weeks
Percentage of planned data and samples collected at primary endpoint (12 weeks)
Overall acceptability
时间窗: 12 weeks
Percentage of participants describing the treatment as acceptable (≥6/10 on 0-10 scale)
次要结局
- First 5 questions of the Inflammatory Bowel Disease-Fatigue questionnaire(12 weeks)
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale(12 weeks)
- Patient Health Questionnaire-9(12 weeks)
- Generalised Anxiety Disorder-7(12 weeks)
- Maudsley 3-item Visual Analogue Scale(12 weeks)
- Pittsburgh Sleep Quality Index(12 weeks)
- Euroqol 5-dimension quality of life questionnaire (EQ-5D-5L)(12 weeks)
- Harvey Bradshaw Index (Crohn's disease patients only)(12 weeks)
- Simple Clinical Colitis Activity Index (ulcerative colitis patients only)(12 weeks)
- Inflammatory Bowel Disease Control Questionnaire(12 weeks)
- Hand grip strength(12 weeks)