A randomised, double blinded, placebo-controlled pilot study assessing the safety and tolerability of arimoclomol in adult patients with inclusion body myositis

niversity College London (UCL) (UK)0 个研究点目标入组 24 人开始时间: 2011年2月2日最近更新: 2017年10月30日

适应症

试验速览

暂无简介。

•1. Meet the diagnostic criteria for definite or probable inclusion body myositis (IBM) (Griggs 1995)
•2. Muscle function adequate for quantitative muscle testing. At least 8 of the following 16 muscle groups have a Manual Muscle Test (MMT) Grade greater than 3, or greater on the modified Medical Research Council Scale
•3. Aged greater than 50 years, either sex
•4. Women must be post-menopausal (no menses in greater than 12 months) or status post-hysterectomy

•1. Presence of any one of the following medical conditions:
•1.1. Diabetes mellitus or patients taking anti-diabetic medications
•1.2. Chronic infection
•1.3. Chronic renal insufficiency
•1.4. Cancer other than skin cancer less than 5 years previously
•1.5. Multiple sclerosis or prior episode of central nervous system demyelination
•1.6. Other chronic serious medical illnesses
•2. Presence of any of the following on routine blood screening:
•2.1. White blood cell count (WBC) less than 300/cm3
•2.2. Platelets less than 100,000/cm3
•2.3. Haematocrit less than 30%
•2.4. Urea greater than 10 mmol/l
•2.5. Creatinine greater than 150 µmol/l
•2.6. Symptomatic liver disease with serum albumin less than 30 g/l
•2.7. Prothrombin time or activated partial thromboplastin greater than upper range of control values
•3. Currently taking riluzole
•4. Women who are pregnant or lactating
•5. History of non-compliance with other therapies
•6. Coexistence of other neuromuscular disease
•7. Drug or alcohol abuse within last 3 months
•8. Inability to give informed consent
•9. Known bleeding disorder (e.g. haemophilia, Von Willebrand's Disease)
•10. Use of potentially nephrotoxic drugs
•11. Prior difficulties with local anaesthetic

发起方

niversity College London (UCL) (UK)