Compassionate Use for BIA 28-6156 in Patients With Parkinson's Disease (PD) Who Have a Pathogenic Variant in the GBA1 Gene (GBA-PD) and Completed the ACTIVATE Study
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 60
研究概览
简要总结
This Program is designed to provide continued access BIA 28-6156, free and compassionately for an eligible patient previously enrolled in the BIA 28-6156-201 (ACTIVATE) clinical study and that had completed the study.
详细描述
A patient taking part in this program will be provided with a 60mg dosage of BIA 28-6156. This will be taken orally once daily (OD) for the duration of the program, currently scheduled to run for 27 months.
Patients will visit the site approximately every 3 months for a drug re-supply. At these visits, the treating physician will reassess if the patient should continue with the treatment.
In case of tolerability concerns, the dose of BIA 28-6156 will be stopped per the treating physician's assessment.
The treating physician should discontinue treatment for the patient and/or withdraw the patient from this program if he/she believes that continuation would be detrimental to the patient's well-being.
Patients may voluntarily withdraw from treatment at any time, for any reason.
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient who completes Part B (Double Blind Treatment arm) of the ACTIVATE study supplied by BIAL R&D Investments, S.A., and falls within one week of completing the safety follow up visit from the ACTIVATE study.
- •A patient is willing to provide written informed consent prior to initiating treatment, in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. A patient who, in the opinion of the treating physician will likely adhere to the program.
- •A patient's treating physician believes the patient could benefit from treatment with BIA 28-
- •Patient has received approval from Supplier or its designee following the treating physician request submission.
- •If a sexually active man or a woman of childbearing potential, the patient agrees to use highly effective birth control or to remain abstinent during the program and for 30 days after the last dose of BIA 28-
- •Acceptable (highly effective) methods of contraception for this study include hormonal contraceptives (combined oral contraceptive, patch, vaginal ring, injectable, or implant); intrauterine device or system; complete abstinence from sexual intercourse if this is the patient's usual and preferred lifestyle; or sexual partner with surgical sterilization (e.g., tubal ligation, hysterectomy and/or bilateral oophorectomy.
排除标准
- •A patient that has previously discontinued for any reason from the BIA 28-6156-201 clinical study.
- •A patient who is pregnant, may be pregnant, lactating, or planning to be pregnant.