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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
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

NCT07522606

No Longer AvailableN/A

Sponsor: Bial R&D Investments, S.A.

Conditions: Parkinson Disease

Interventions: BIA 28-6156

Countries: United States, Italy, Portugal, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Study type: EXPANDED_ACCESS

Eligibility criteria
Inclusion Criteria:

1. 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.
2. 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.
3. A patient's treating physician believes the patient could benefit from treatment with BIA 28-6156.
4. Patient has received approval from Supplier or its designee following the treating physician request submission.
5. 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 28-6156. 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.

Exclusion Criteria:

1. A patient that has previously discontinued for any reason from the BIA 28-6156-201 clinical study.
2. A patient who is pregnant, may be pregnant, lactating, or planning to be pregnant.
Locations (36)
  • Phoenix, Arizona, United States
  • Aurora, Colorado, United States
  • Boca Raton, Florida, United States
  • Miami, Florida, United States
  • Chicago, Illinois, United States
  • Kansas City, Kansas, United States
  • Lexington, Kentucky, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Saint Paul, Minnesota, United States
  • Cleveland, Ohio, United States
  • Charleston, South Carolina, United States
  • Nashville, Tennessee, United States
  • Salt Lake City, Utah, United States
  • Seattle, Washington, United States
  • Spokane, Washington, United States
  • Bologna, Italy
  • Brescia, Italy
  • Brindisi, Italy
  • Milan, Italy
  • Naples, Italy
  • Padova, Italy
  • Roma, Italy
  • Salerno, Italy
  • Guimarães, Portugal
  • Badalona, Spain
  • Barakaldo, Spain
  • Barcelona, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • + 6 more on CT.gov