EUCTR2007-005088-82-IT进行中（未招募）不适用
A multi-centre, randomized, double-blind, placebo-controlled, two-period, crossover proof-of-concept study in male patients with Fragile X Syndrome to assess the efficacy, safety and tolerability of multiple oral doses of AFQ056 - ND
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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
- 性别
- Male
入选标准
- •1. Male, non-smoking patients between 18 and 35 years of age (both inclusive). 2. Patients with confirmed diagnosis of Fragile X based upon genetic testing results (full mutation > 200 CGG repeats), a Clinical Global Impression Severity Score (CGI-S) of > 4 (moderately ill), a score of >20 in the ABC-C scale (performed at screening) and a mental age of ≥ 48 months as measured by the Standford-Binet test. 3. Patients treated with psychotropic treatment and/or anticonvulsant therapy are allowed to enter the study provided that they are on a stable regimen for at least 4 weeks prior to randomization. 4. Patients must be using a double-barrier local contraception for the entire duration of the study (from screening up to the study completion visit), and refrain from fathering a child in the 3 months following last study drug administration. 5. Patients whose legal guardian has signed an Informed Consent (for the exploratory substudy, an additional separate Informed Consent has to be signed).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with DSM-IV diagnosis of schizophrenia. 2. Patients with a history and/or presence of psychosis, confusional states and/or repeated hallucinations. 3. Patients with a history of seizures in the past 5 years without any therapeutic treatment controlling the disorders. 4. Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation. 5. Significant illness within two weeks prior to dosing. 6. A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome. 7. History of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension, sinus arrhythmia). 8. History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated) 9. History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). 10. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the patient in case of participation in the study. The investigator should be guided by evidence of any of the following: history of ulcers, gastrointestinal or rectal bleeding; This document (090095a880ef01bb in docbase CREDI_BS) has been digitally signed with external signatures using Entrust PKI. Signatures manifested as of 10/1/2007 9:29:16 AM, signing status at this time: Completed (1 of 1 signatures) Approved for report publication by Magnone Maria-Chiara in Basel at Mon, 01 Oct 2007 09:28:11 CEST Novartis Confidential Page 43 Protocol AFQ056A2204 (Version 01) AFQ056 history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; history or clinical evidence of pancreatic injury or pancreatitis; clinical evidence of liver disease or liver injury as indicated by clinically relevant abnormal liver function tests such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin. If the total bilirubin concentration is increased above 1.5 times the upper normal limit total bilirubin should be differentiated into the direct and indirect reacting bilirubin and the Investigator will make his judgment on the clinical relevance of these data. history or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria); evidence of urinary obstruction or difficulty in voiding at screening; 11. Patients using (or have used within four weeks before randomization) concomitant medications that are potent inhibitors of CYP3A4 (e.g., ketoconazole, ritonavir, etc.) 12. Patients who in the opinion of the investigator, are unsuitable in any other way to participate in this study including being unable to comply with the requirements of the study or displaying abnormalities in safety assessments at baseline .
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