EUCTR2015-003513-24-IT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 - OPEN-LABEL EXTENSION and FOLLOW-UP of 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. Subjects 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. Subjects 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 subject and /or partner include: True abstinence when
- •this is in line with the preferred and usual lifestyle of the subject, 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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