ISRCTN83178718已完成4 期
A double-blind randomised controlled trial of lithium carbonate in patients with amyotrophic lateral sclerosis
King's College London (UK)0 个研究点目标入组 220 人开始时间: 2009年5月8日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
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. Patients with possible, laboratory-supported probable, probable or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria (The Airlie House Statement: http://www.wfnals.org). These criteria are internationally accepted research diagnostic criteria with high specificity and sensitivity. The onset form (bulbar or limb) and disease type (familial or sporadic) will be recorded; source documents will include a full report of an electromyogram (EMG) reported by an experienced neurophysiologist as compatible with ALS. The neurological exam should be performed by a physician.
- •2. Disease duration greater than or equal to 6 months and less than or equal to 36 calendar months (inclusive), with disease onset defined as date of first muscle weakness, or dysarthria
- •3. SVC greater than or equal to 60% of predicted within 1 month prior to randomisation
- •4. Aged greater than or equal to 18 years (inclusive), either sex
- •5. In the case of a female with childbearing potential, the patient must not be pregnant or breast-feeding. Women of childbearing potential will have a urine pregnancy test before randomisation and at each clinic visit. The results of those must be negative. Women of childbearing potential should use adequate contraception.
- •6. Continuously treated with riluzole for at least 4 weeks prior to screening (28 days inclusive) and stabilised at 100 mg/day (50 mg twice daily [bid]) without significant adverse drug reactions
- •7. Capable of understanding the information given and giving fully informed consent prior to any study specific procedures
排除标准
- •1. Participation in another therapeutic study within the preceding 12 weeks or use of other investigational drugs or agents
- •2. Tracheostomy, or assisted ventilation of any type during the preceding three months
- •3. Existing gastrostomy, unless elective and not currently used for nutritional support or hydration
- •4. Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
- •5. Presence of any concomitant life-threatening disease or any disease or impairment likely to interfere with functional assessment
- •6. Confirmed hepatic insufficiency or abnormal liver function (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] greater than 1.5 times the upper limit of the normal range) within one month of randomisation. That blood test may be repeated in the case of initial abnormal results; if the levels return to normal, the patient may then be included in the study.
- •7. Renal insufficiency (serum creatinine greater than upper limit of normal [ULN] for the centre/local laboratory) within one month of randomisation. That blood test may be repeated in the case of initial abnormal results; if the level returns to normal, the patient may then be included in the study.
- •8. Recorded diagnosis or evidence of major psychiatric disorder or clinically evident dementia
- •9. Known allergy or hypersensitivity to lithium, or its excipients
- •10. Likely to be uncooperative or to fail to comply with the trial requirements or to be inaccessible in the event of an emergency
- •11. Subjects with significant haematological, biochemical and autoimmune abnormalities, as judged by the study physician
- •12. If a woman of childbearing potential, unable or unwilling to use effective contraception during the study
- •13. Patients with active inflammation/infection at screening or baseline (day 0). Patients presenting with active inflammation/infection can be reassessed at a later date, and included in the trial if the infection/inflammation has cleared.
- •14. Patients already taking lithium in any form
- •15. Presence of a medical condition contra-indicative to the use of lithium, according to the British National Formulary (BNF) (http://www.bnf.org/bnf/)
研究者
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