NL-OMON52830已完成不适用
Interventional, open-label, exploratory study, investigating the safety, tolerability, pharmacokinetics, and efficacy of Lu AF28996 in patients with Parkinson*s disease - CS0334 Lundbeck (18252A)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
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
- 18 至 99（—）
入选标准
- •- The patient is able to read and understand the Subject Information Sheet and
- •Informed Consent Form.
- •- The patient has signed the study-specific Informed Consent Form.
- •- The patient is diagnosed with idiopathic Parkinson*s disease (consistent with
- •the UK Parkinson*s Disease Society Brain Bank Criteria for the Diagnosis of PD)
- •and should not have more than 1 first-degree relative with PD.
- •- The patient*s Modified Hoehn and Yahr score is *3 in the ON state and *4 in
- •the OFF state.
- •- The patient experiences well recognizable and predictable motor fluctuations
- •(at least 1.5 hours of OFF-periods in the awake time, predictable morning OFF
- •episodes included) causing clinically significant disability during the 7-week
- •Screening Period.
排除标准
- •- The patient has previously been enrolled in this study.
- •- The patient takes or has taken disallowed recent or concomitant medication
- •(specified in Appendix II of the CSP) or it is anticipated that the patient
- •will require treatment with at least one of the disallowed concomitant
- •medications during the study. Patients who have taken any non-prescribed
- •systemic or topical medication may participate in the study if, in the opinion
- •of the investigator, the medication will not interfere with the study
- •procedures, study results, or compromise safety.
- •- The patient is a member of the study personnel or of their immediate
- •families, or is a subordinate (or immediate family member of a subordinate) to
- •any of the study personnel.
研究者
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