EUCTR2015-003513-24-GB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
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.
- •3. Patients who have a good response to levodopa in the opinion of the investigator
- •4. Patients 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 another clinical trial other than IN 11 004 and receipt of an investigational medication, other than those administered in IN 11 004, within 28 days prior to the planned start of treatment.
- •2. Previous or planned functional neurosurgical or Duodepa 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. 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 medically acceptable methods 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 > 2 years) 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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