ISRCTN13106662进行中（未招募）3 期
Modafinil In Debilitating Fatigue After Stroke 2 (MIDAS2 Part I and MIDAS2 Part II tele health)
niversity of Newcastle Australia0 个研究点目标入组 300 人开始时间: 2023年5月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 18 years of age or older
- •2. Have suffered a stroke (ischaemic / Haemorrhagic) at least 3 months ago
- •3. Have persistent self-reported fatigue with an MFI score of 60 or more
- •4. Modified Rankin Score (mRS) of 3 or less
- •5. Can speak reasonable English, understand instructions and be able to complete tests and questionnaires on their own or with minimal support
- •6. Able to give informed consent to participate in the study, in accordance with the ICH GCP guidelines, and local regulations, before initiating any study-related procedures
排除标准
- •1. An active, symptomatic or untreated anxiety disorder who, based on the clinical judgement of the investigator, could be prone to an exacerbation of anxiety with the use of modafinil (Note: Subjects with well-controlled anxiety who are on medication are eligible for consideration for inclusion in the trial)
- •2. An active, symptomatic or untreated depression who, based on the clinical judgement of the investigator could be prone to an exacerbation of depression or the development of agitation (Note: Subjects with well-controlled depression who are stable and/or have been on antidepressant medication for at least 6 months are eligible for consideration for inclusion in the trial)
- •3. Pre-existing dementia or other neuropsychiatric disease
- •4. Other diagnoses with fatigue as a known symptom e.g. chronic fatigue syndrome, multiple sclerosis, narcolepsy
- •5. Current or past drug abuse
- •6. Known contraindication to treatment with modafinil
- •7. Known active malignancy, intracranial tumour, subdural or epidural hematoma
- •8. Severe renal or hepatic impairment (GFR <15mL/min)
- •9. Unstable or poorly controlled epilepsy where the investigator is concerned about the potential for drug interactions. Refer to appendix 2 for specific medication guidance
- •10. Benzodiazepines or other hypno-sedative drugs which may interact with modafinil as per specific medication guidance provided in appendix 2
- •11. Clinical suspicion of sleep apnoea. If the investigator suspects on clinical grounds, that fatigue is related to sleep apnoea, an Epworth Sleepiness Scale must be undertaken. If the score is >10, overnight pulse oximetry monitoring or a sleep study must be undertaken to exclude sleep apnoea
- •12. Participant is receiving immunosuppressive therapy or has a known immunodeficiency state, e.g., HIV
- •13. Pregnant or breastfeeding women. Women of childbearing potential will need to have a negative pregnancy test at screening and should agree to using an acceptable barrier form of birth control. The effectiveness of steroidal contraceptives (contraceptive pill, implants, intrauterine devices (IUDs) or patches, etc.) may be impaired due to induction of CYP3A4/5 by modafinil. Alternative or concomitant methods of contraception are recommended for patients treated with modafinil. Acceptable methods of contraception should continue to be used for at least two months after ingestion of the final study dose.
- •14. Are likely unable to complete protocol requirements due to logistical factors such as inadequate Information and communication technology (ICT) capability or inability to attend for face-to-face follow-up, as assessed and confirmed by the local investigator
研究者
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