An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome

ovartis Pharma Services AG0 个研究点目标入组 180 人开始时间: 2012年8月24日最近更新: 2016年9月12日

适应症

试验速览

暂无简介。

•Group 1 patients:
•Must have completed the CAFQ056B2214 core study within one week of enrollment into the open-label study
•Has a caregiver who spends, on average, at least 6 hours per day with the patient , who is willing to and capable of supervising treatment, providing input into efficacy and safety assessments, and accompanying the patient to study visits.
•Group 2 patients:
•Must meet one of the following conditions:
•o completed Study CAFQ056B2131
•o completed Study CAFQ056B2214 but enrollment into the current study was delayed for more than a week
•o discontinued prematurely from Study CAFQ056B2214 due to intolerability of the dosage in the patient’s assigned treatment group
•Has a caregiver who spends, on average, at least 6 hours per day with the patient , who is willing to and capable of supervising treatment, providing input into efficacy and safety assessments, and accompanying the patient to study visits
•Other protocol-defined inclusion criteria may apply
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 160
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Discontinuation from CAFQ056B2214 or CAFQ056B2131 studies due to safety reasons
•Female patients who are sexually active at any time during the study
•Any advanced, severe or unstable disease
•History and/or presence of schizophrenia, bipolar disease, psychosis, confusional states and/or repeated hallucinations as per DSM-IV criteria
•History of suicidal behavior or considered a high suicidal risk
•History of severe self-injurious behavior
•History of uncontrolled seizure disorder or resistant to therapy within the past 2 years (Patients who are clinically stable under anti-convulsant therapy for the past 2 years are not excluded)
•History of clinically significant allergies requiring hospitalization or non-inhaled corticosteroid therapy (asthma, anaphylaxis, etc.)
•History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether or not there is evidence of local recurrence or metastases
•patients who are using (or used within 6 weeks before baseline) digoxin or warfarin
•Using (or used within 6 weeks before randomization) concomitant medications that are potent inhibitors or inducers of CYP3A4
•Using glutamatergic agents (riluzole, memantine, etc.) or lithium within 6 weeks of baseline
•patients who weigh less than 32 kg (= 10th percentile of body weight for a 12-year old child)
•Other protocol-defined exclusion criteria may apply

发起方