EUCTR2005-000444-84-AT进行中（未招募）不适用
An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 800
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
- All
入选标准
- •1. The patient has participated in and completed the previous PADDY 1 or PADDY 2 study.
- •2. The patient has given his/her informed consent to participate in the PADDY-O study. (Note: The patient must have given written informed consent before any study-related activities are carried out.)
- •3. Visit 8 of the PADDY study and the first visit of the PADDY-O study are on the same day or, if on different days, they are not separated by a period exceeding one month.
- •4. (For females of child-bearing potential) The patient is using a reliable method of contraception AND gives a negative result in a serum ß-HCG test for pregnancy at entry into the study.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The patient has, within the four weeks up to inclusion, started treatment with any classical or atypical neuroleptics (including metoclopramide) and/or antidepressants and/or anxiolytics (including buspirone).
- •2. The patient's dosage with any of the medications listed in (1) above has changed within the four weeks up to inclusion.
- •3. Any commencement or change of dosage with any of the medications listed in (1) above during the study period is anticipated.
- •4. The patient experienced major tolerability problems during the PADDY study that were/are judged by the investigator as being sufficient to preclude participation in the PADDY-O study.
- •5. Known hypersensitivity to ACTH. (In establishing this, the investigator should check the patient's records from the PADDY study.)
- •6. (For female patients) The patient is pregnant or lactating.
- •7. The patient is participating in another clinical study or has done so within the past 30 days - apart from the PADDY 1 or PADDY 2 study.
- •8. The patient has relevant renal impairment as measured by creatinine >2 x ULN (upper limit of normal).
- •9. The patient has relevant hepatic impairment as measured by total bilirubin >2 x ULN or has a history of moderate or severe hepatic insufficiency or has moderate or severe liver cirrhosis.
- •10. The patient has received neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation, thalamotomy etc.) or is scheduled to do so during the study period.
- •11. The patient has any clinically significant illness that, in the investigator's opinion, might interfere with the patient's ability to participate in the study.
- •12. The patient showed major non-compliance in respect of intake of study medication during the respective PADDY study.
- •13. The patient is suffering from dementia, or any other psychiatric illness that prevents him/her from giving informed consent.
- •14. The patient has legal incapacity or limited legal capacity.
研究者
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