This Program is designed to provide continued access BIA 28-6156, free andcompassionately for an eligible patient previously enrolled in the BIA 28-6156-201(ACTIVATE) clinical study and that had completed the study.
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.
Drug: BIA 28-6156
60mg dosage of BIA 28-6156 taken orally once daily
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.
Barrow Neurological Institute
Phoenix, Arizona, United States
University of Colorado
Aurora, Colorado, United States
Parkinson's Center and Movement Disorders of Boca Raton
Boca Raton, Florida, United States
University of Miami, Dept. of Neurology
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Park Nicollet Struther's Parkinson's Center (Struthers Parkinsons Center at HealthPartners)
Saint Paul, Minnesota, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
MUSC
Charleston, South Carolina, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
Intermountain Healthcare
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
Inland Northwest Research
Spokane, Washington, United States
IRCCS Istituto Delle Scienze Neurologiche DI
Bologna, Italy
Spedali Civilia di Brescia
Brescia, Italy
Ospedale Antonio Perrino
Brindisi, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia I
Naples, Italy
Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Neurologica
Padova, Italy
IRCSS San Raffaele Pisana
Roma, Italy
A.O.U. San Giovanni di Dio Ruggi d'Aragona Centro Parkinson- Piano Rialzato Corpo QT
Salerno, Italy
Hospital Senhora da Oliveira de Guimaraes
Guimarães, Portugal
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Universitario Cruces
Barakaldo, Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
Hospital Vall D´Hebron
Barcelona, Spain
Hospital Universitaio de La Princesa
Madrid, Spain
Hospital Ruber Internacional
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
NHS Tayside-Ninewells Hospital and Medical School
Dundee, United Kingdom
King's College London - David Goldberg Centre
London, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital
Newcastle upon Tyne, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
Raquel Costa
00351229866100
raquel.costa@bial.com
Miguel Fonseca
00351229866100
miguel.fonseca@bial.com
Not Provided