European trial of Minocycline IN Amyotrophic Lateral Sclerosis

King's College London (UK)0 个研究点目标入组 1,000 人开始时间: 2007年5月3日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Possible, probable (clinically or laboratory) 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/). 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
•2. Disease duration more than 6 months (required by the El Escorial Criteria as the minimum time required to determine that there has been progression) and less than 5 years (inclusive); disease onset defined as date of first muscle weakness
•3. Vital Capacity (VC) greater than or equal to 40 % of predicted
•4. Age: greater than or equal to 18 years (inclusive)
•5. Sex: male or female. In the case of a female with childbearing potential, the patient must use adequate contraceptive measures and must not be pregnant or breast-feeding
•6. Continuously treated with riluzole for at least 3 months and stabilised at 100 mg/day (50 mg twice a day) without significant adverse drug reactions
•7. Capable of understanding the information given and giving fully informed consent

•1. Previous participation in another clinical study within the preceding 12 weeks
•2. Tracheostomy, assisted ventilation of any type during the preceding three months
•3. Existing gastrostomy
•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] and/or alanine aminotransferase [ALT] greater than 1.5 the upper limit of the normal range)
•7. Renal insufficiency (serum creatinine greater than 200 µmol/L [2.26 mg/dL])
•8. Evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
•9. Known hypersensitivity to any component of the study drugs or to drugs in this class
•10. Likely to be unco-operative or to fail to comply with the trial requirements or to be inaccessible in the event of an emergency
•11. Unable or unwilling to use an effective method of contraception if a woman of childbearing age
•We have chosen inclusion criteria that are permissive (i.e., sensitive) without sacrificing specificity. The El Escorial Criteria of the World Federation of Neurology (The ?Airlie House Statement?: http://www.wfnals.org/) are internationally accepted research diagnostic criteria with high specificity and sensitivity.

发起方

King's College London (UK)