EUCTR2015-003513-24-DE进行中（未招募）1 期
An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 266
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.Patients who successfully completed the core study ?IN 11 004 and, in the opinion of the Investigator would benefit from long-term treatment with AP-CD/LD
- •2.Continue to carry the diagnosis of Parkinson`s disease consistent with UK brain bank criteria
- •2.Patients who have a good response to levodopa in the opinion of the investigator
- •3.Subjects able and willing to give written (signed and dated) informed consent to participate in 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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 186
排除标准
- •1.Participation in a clinical trial other than study IN 11 004 and receipt of an investigational medication other than those administered in study IN 11 004, within 28 days prior to the planned
- •start of treatment
- •2.Previous or planned functional neurosurgical or Duodopa treatment for
- •Parkinson's Disease (e.g., procedures including ablation or deep brain stimulation)
- •3.Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline Visit or planned administration during study participation.
- •4.If, in the opinion of the Investigator, subject should not participate
- •in the study
- •5.Women who are pregnant or nursing. Women of childbearing
- •potential who are not willing to use a medically acceptable method of contraception. Medically
- •acceptable methods of contraception that may be used by the patient and /or partner include: True
- •abstinence when this is in line with the preferred and usual lifestyle of the patient, oral contraceptive agents, intrauterine devices (IUDs), implantable contraceptives (e.g., Norplant),
- •transdermal hormonal contraceptives (e.g., Ortho-Evra), and injectable contraceptives (e.g.,
- •Depo-Provera), condom and /or diaphragm, diaphragm with vaginal spermicide, surgical sterilization
- •(6 months), or postmenopausal females (no menstrual period for > 2years) or vasectomy ( > 6 months)
- •. The current contraceptive therapy must be maintained through the end of the study (End of study
- •visit or final follow-up phone visit, whichever is later).
- •Hormonal contraceptive therapy must be a stable dose for at least 90
- •days prior to first study drug administration.
研究者
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