ACTRN12616000178448终止2 期
Clozapine and risperidone for the treatment of progressive multiple sclerosis (CRISP)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Progressive multiple sclerosis with the continuous worsening of neurological impairment over at least 6 or 12 months; aged 18 years to 70 years; EDSS at baseline of 3.5 to 7.0; willing and able to participate in the trial and provide written, informed consent
排除标准
- •1.Relapsing-remitting MS
- •2.Pregnant or lactating women
- •3.Patients unable to undergo regular blood tests or MRI scans
- •4.Patients with contraindications to clozapine or risperidone
- •5.Known hypersensitivity to clozapine, risperidone or to any of the excipients thereof
- •6.Reported past intolerance to clozapine or risperidone
- •7.Postural hypotension, defined as a reduction in systolic blood pressure (BP) of 20 mmHg within 2 – 5 minutes of standing up
- •8.Dysphagia
- •9.Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months
- •10.Concomitant disease likely to interfere with the trial medication (e.g. capable of altering absorption, metabolism or elimination of the trial drug)
- •11.History of toxic or idiosyncratic granulocytopenia/agranulocytosis (with the exception of granulocytopenia/agranulocytosis from previous chemotherapy)
- •12.Impaired bone marrow function
- •13.Alcoholic and other toxic psychoses, drug intoxication, comatose conditions
- •14.History of circulatory collapse and/or CNS depression of any cause
- •15.Moderate or severe renal or cardiac disorders (e.g. myocarditis)
- •16.Hepatic impairment; active liver disease associated with nausea, anorexia or jaundice; progressive liver disease, hepatic failure
- •17.Paralytic ileus
- •18.History of cardiovascular disease
- •19.Elevated glycosylated haemoglobin levels (HbA1c greater than or equal to 41mmol/mol)
- •20.Hyperthyroidism
- •21.Serious medical co-morbid illness or any other disease or condition which, in the opinion of the investigator, means that it would not be in the patient’s best interests to participate in the study
- •22.A white blood cell (WBC) and differential blood count taken within 10 days of starting treatment shows a WBC count of < 3500/mm3 and absolute neutrophil count (ANC) of < 2000/mm3
- •23.An abnormal platelet count taken within 10 days of starting treatment
- •24.Concomitant use of medications known to affect clozapine treatment:
- •a.Fluvoxamine, ciprofloxacin, or enoxacin
- •b.Oral contraceptives
- •c.Cimetidine, escitalopram, erythromycin, paroxetine, buproprion, fluoxetine, quinidine, duloxetine, terbinafine, or sertraline
- •25.Concomitant use of medications known to reduce the effectiveness of clozapine treatment, including phenytoin, carbmazepine, St John’s wort, rifampin
- •26.Patients taking drugs that increase the risk of agranulocytosis, including carbamazepine, phenylbutazone, azapropazone, co-trimoxazole, penicillamine, cytotoxic agents, sulphonamide antibiotics, or chloramphenicol
- •27.Patients taking medications that prolong the QT interval or inhibit clozapine metabolism, including ziprasidone, iloperidone, chlorpromazine, thioridazine, mesoridazine, droperidol, pimozide, erythromycin, gatifloxacin, moxifloxacin, sparfloxacin, quinidine, procainamide, amiodarone, sotalol, pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol, or tacrolimus.
- •28.Patients taking other medications that may potentiate the side effects of treatment with atypical antipsychotics, including frusemide or anti-cholinesterase treatment
- •29.Treatment with cyclophosphamide or mitoxantrone within 12 months; systemic corticosteroid therapy within 30 days; treatment with interferon beta, glatiramer acetate, natalizumab, plasmapheresis, or intravenous immunoglobulin within 60 days
研究者
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