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[求助]
Xadago - EPAR - Public assessment report + 临床药学 + 2015/04/10
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求专业人士帮忙翻译临床研究资料，多谢啊多谢！！！ Adverse events with an occurrence rate of ≥5% have been underlined Although the incidence of bradycardia and arrhythmia as adverse events was slightly higher in the active treatment arms as compared to placebo, there was no clear signal of abnormalities from the ECGs, which were routinely monitored in the therapeutic clinical trials. There was no evidence of effect of safinamide on ECGs from the therapeutic clinical trials. In a randomized, double blind, placebo-controlled study in healthy subjects (trial 28559) the effects of Safinamide (100 and 350mg) on the QT/QTc interval have been investigated with Moxifloxacine (400mg) as a positive control. Safinamide was not associated with QTc prolongation in this trial. By contrast, in both the Moxifloxacin and supratherapeutic Safinamide group a mild PR shortening was observed (<4 msec for both groups). This level of effect, if caused by the drug, was considered of no clinical relevance. 2.8.2.6. Skin and subcutaneous tissue disorders For ESPD, the occurrence of skin and subcutaneous disorders decreased with increasing Safinamide dosage (50mg 11.7%; 150-200mg 4.5%). For LSPD patients, the occurrence rate was similar for 50 and 100mg Safinamide: 11.5%. These rates were higher compared to placebo (9.9%). In the open label studies 10% of patients experienced skin and subcutaneous tissue disorders. In this patient group, one patient experienced a melanoma. In the double-blind placebo-controlled trials none of the patients experienced melanoma. 2.8.2.7. Ocular adverse events In repeated-dose studies with Safinamide in rats retinal degeneration has been observed. In the chronic studies, these retinal alterations progressed to a stage where the outer nuclear layer disappeared and changes to the pigment epithelium. Loss of nuclei from the inner nuclear layer was also present. The lowest dose producing retinal atrophy was 15mg/kg/day. Thus far, these changes have not been noted in any human or non-human primate species in which ocular investigations have been performed. Once the potential of retinal degeneration had been observed, it was decided to introduce ocular investigations for the patients enrolled in the safinamide development program. Ocular examinations included: visual acuity, LogMAR assessment (chart to determine visual acuity), colour vision examination, funduscopy assessment, visual field assessment, global impression score of ocular function, occurrence of ocular TEAEs, ocular coherence tomography (OCT), and electroretinograms (ERG). The extent to which this was done differed between studies and research sites. Ocular images were assessed centrally by a neuro-ophthalmologist. As represented in the next Table 37, 30 retinal degeneration was observed in 2.2% of ESPD patients treated with 150-200mg per day in Study 017, in which there were no baseline ocular assessments. Retinal degeneration has not been observed in other ESPD patients. Retinal degeneration (LSPD patients) was observed in 2.1% of patients treated with 50mg safinamide per day and in 0.2% of patients who received 100mg safinamide per day. Also one placebo-treated patient experienced retinal degeneration (0.2% from the Placebo group). Cataract occurred in 3.5-5.6% of ESPD patients, compared to 6.3-14% of LSPD patients. Conjunctivitis occurred in less than 2% of both ESPD and LSPD patients. |
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