PER-032-08已完成未知
A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist
MERCK SERONO INTERNATIONAL S.A.,0 个研究点目标入组 46 人开始时间: 2008年7月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30 至 80（—）
入选标准
- •Have a diagnosis of idiopathic Parkinson´s disease less than 5 years old, with stage I-III of Hoehn & Yahr. The diagnosis must be based on the clinical history and the neurological examination.
- •Be between 30 and 80 years of age, inclusive, at the time of selection.
- •In the case of women, being post-menopausal for at least 2 years, being surgically sterilized or having undergone a hysterectomy, or, in the case of women with the capacity to procreate, be willing to avoid pregnancy through the use of an appropriate contraceptive method as defined in Section 6.4.9 during the previous four weeks [at the start of treatment], during the same, and for the four weeks following the last dose of study medication. For the purposes of this study, women with the capacity to procreate all female subjects who have gone through puberty, unless they have been post-menopausal for at least two years, have been surgically sterilized or sexually inactive.
- •Be receiving treatment with a single dopamine agonist in a stable dose for at least 4 weeks before the screening visit.
- •Have the willingness and ability to participate in the study and have provided written informed consent.
排除标准
- •Any indication of any form of Parkinson´s disease, other than idiopathic Parkinson´s disease.
- •In the case of women, pregnancy or breastfeeding.
- •Current diagnosis of substance abuse or history of alcoholism or drug abuse in the last 3 months.
- •Currently experiencing phenomena of dissipation of the therapeutic effect of the final dose or on-off phenomena, biphasic dyskinesias or peak of incapacitating doses, or unpredictable or widely variable fluctuations.
- •Currently affected by a clinically significant disease of the gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular type, including acute gastric ulcer, inadequately controlled hypertension, asthma, chronic obstructive pulmonary disease (COPD) and type I diabetes. with a history of gastric ulcer who have not had a recent episode of acute gastritis and are not currently experiencing gastric pain will be eligible for inclusion.
- •Second or third degree atrio-ventricular block or sick sinus syndrome, uncontrolled uricular fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months prior to the screening visit, or abnormalities significant in the ECG, including QTc> 450 msec (men) or> 470 msec (women), in which case the QTc is based on the Bazett correction method.
- •Have previously received treatment with safinamide.
- •A concomitant disease that is likely to interfere with the study medication (eg, capable of altering the absorption, metabolism, or elimination of the study drug).
- •History of, or current picture of, psychosis (eg, schizophrenia or psychotic depression), or a score> 3 on item 2 (thought disorder) or on item 3 (depression) of UPDRS Section I in the moment of selection.
- •Evidence of dementia or cognitive dysfunction, indicated by a score in the MMSE <24, or a score> 3 in item 1 (mental state) of the UPDRS, Section I at the time of selection.
- •Depression, indicated by a score> 17 in the GRID-HAMD (scale of 17 items) at the time of selection.
- •History of allergic response to anticonvulsants or antiparkinsonians.
- •Mental or physical disorder (eg, neurotic behavior, disabling degenerative arthritis, or limb amputation) that could impede effectiveness or safety evaluations.
- •Hypersensitivity or contraindications to MAO-B inhibitors.
- •Current history of severe dizziness or fainting when standing up, as a consequence of postural hypotension.
- •Neoplastic disorder, which is active or has been in remission for less than a year.
- •Participation in a clinical study within 30 days before entering the study (screening visit) or having received treatment with a compound under investigation within 30 days or 5 half-lives, which implies a longer period, prior to the selection.
- •Treatment of your Parkinson´s symptoms with a medication, other than a stable dose of a single dopamine agonist, during the 8 weeks prior to the screening visit.
- •Treatment with any agent known to cause significant inhibition or induction of the drug´s metabolizing enzymes (eg, barbiturates, phenothiazines, etc.) within 4 weeks prior to the screening visit.
- •Treatment with opioids (eg, tramadol, meperidine derivatives), ISRN (eg, venlafaxine, duloxetine), tri- or tetra-cyclic antidepressants, MAO inhibitors (eg, selegiline) , within 8 weeks prior to the screening visit. The use of dextromethorphan will be allowed if it is for the treatment of cough.
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