EUCTR2016-000342-60-GB进行中（未招募）1 期
Fatigue in Sarcoidosis - A feasibility study investigating the treatment of fatigue in stable sarcoidosis patients using methylphenidate - Fatigue in Sarcoidosis: Treatment with Methylphenidate
orfolk and Norwich University Hospital0 个研究点目标入组 30 人开始时间: 2019年2月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.A proven diagnosis of sarcoidosis – this is defined as either a biopsy-proven disease (non-caseating granulomas from a tissue biopsy), or a diagnosis of sarcoidosis agreed by an interstitial lung disease multidisciplinary team (ILD MDT) meeting.
- •2.Stable disease (treatment unchanged for 6 weeks, without anticipation of change in treatment during trial period)
- •3.Able to give informed consent.
- •4.Fatigue Assessment Sscale (FAS) score greater than 21 units (defined cut off for significant fatigue present)
- •5.In patients on warfarin therapy – Willing to consent to increased frequency of monitoring
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Evidence of co-existing obstructive sleep apnoea. Patients screened with a STOP-Bang” questionnaire score of greater than 4 must undertake overnight oximetry; they are only excluded if this shows a desaturation index of more than 15 events per hour on overnight oximetry. Below this participants are eligible for inclusion.
- •2.Documented history of significant cardiac disease (including cardiac sarcoid) OR associated disease which would increase risk of underlying coronary artery disease (cerebrovascular disease, previous stroke or peripheral vascular disease). Definitively treated cardiac disease e.g. previous myocardial infarction treated with stents or coronary artery bypass grafting with no ongoing symptoms is permitted.
- •3.Hyperthyroidism evidenced by abnormal screening thyroid function tests (TSH outside normal range of 0.35 – 3.50 mU/L or T4 outside normal range of 8 – 21 pmol/L).
- •4.History of seizures, excluding febrile convulsions whilst an infant.
- •5.Abnormal electrocardiogram (ECG) with evidence of arrhythmia (except first degree heart block which has been stable for 3 months).
- •6.Concomitant therapy with the following drugs:
- •a.Tricyclic antidepressants
- •b.Monoamine oxidase inhibitors
- •c.Tramadol or buprenorphine
- •e.Haloperidol and atypical antipsychotics
- •7.Glaucoma or raised intra-ocular pressure for any reason.
- •8.Patients with established liver disease defined as Child-Pugh class B or C.
- •9.Documented medical history of psychiatric disorders (excluding depression)
- •10.History of drug-dependence or addiction at any time
- •11.Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- •12.Female patient of childbearing potential unable or unwilling to take two acceptable forms of contraception (see below)
- •13.Receiving an investigational drug or biological agent within 6 weeks (or 5 times the half-life if this is longer) prior to study entry.
- •Exclusion criteria on pregnancy
- •Female patients of childbearing potential and unable or unwilling to take two of the following acceptable methods of contraception for the duration of their treatment will be excluded from participating in this trial:
- •Established use of oral, injected or implanted hormonal methods of contraception
- •Barrier methods of contraception (condom or occlusive cap with spermicide – please note, use of spermicide without a form of barrier contraception is not an acceptable form of contraception)
- •Absolute and continuous abstinence. Periodic abstinence (calendar, ovulation, symptothermal, post-ovulation) or withdrawal are not acceptable methods of contraception
- •For the purposes of this trial the definition of a woman of childbearing potential is a sexually mature woman (i.e. has experienced menstruation) who has not been postmenopausal for 12 consecutive months (i.e. who has had menses at any time in the last 12 months without an alternative medical cause).
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