AzTrials
AzTrials

Parkinson's DiseasePhase 2ACTIVATENCT05819359

Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD

A Phase 2 study testing BIA 28-6156 10 mg and BIA 28-6156 60 mg in people with Parkinson's Disease, run by Bial R&D Investments, S.A. at 95 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this randomized, double-blind, placebo-controlled study is to assess the efficacy of BIA 28-6156 over placebo in delaying clinical meaningful motor progression over 78 weeks in subjects with Parkinson's disease who have a pathogenic variant in the glucocerebrosidase 1 (GBA1) gene (GBA-PD). Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
BIA 28-6156 10 mg and BIA 28-6156 60 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
273 participants
Where
95 sitesin 11 countries
Study dates
31 Mar 2023to 9 Sep 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who satisfy all of the following criteria will be eligible for Part A (Genetic Screening) of the study:
  • The subject is ≥35 and ≤80 years of age at the time of informed consent.
  • The subject has a clinical diagnosis of PD for at least 1 year and for no longer than 7 years before initiation of screening (for Part A), as confirmed by a neurologist using the MDS Criteria for Parkinson's Disease.
  • The subject has a modified Hoehn and Yahr score ≤2.5.
  • The subject is receiving symptomatic treatment for PD.
  • The subject is capable of giving signed informed consent.
Show all 15Show fewer
  • Subjects who satisfy all the following criteria will be eligible for Part B (Double-Blind Treatment) of the study:
  • Informed Consent - The subject is capable of giving signed informed consent.
  • The subject has a known GBA-PD risk-associated variant (as determined in Part A [Genetic Screening] of this study).
  • The subject has a score ≥22 on the Montreal Cognitive Assessment (MoCA) scale.
  • The subject does not have severe motor fluctuations or disabling dyskinesias in the clinical judgment of the investigator.
  • The subject has been on stable doses of PD medications for at least 30 days (at least 60 days for rasagiline) before initiation of screening in Part B (Double-Blind Treatment).
  • The subject is able to comply with the study restrictions.
  • The subject has a body mass index (BMI) of 18 to 40 kg/m2.
  • If a sexually active man or a women of childbearing potential, the subject agrees to use highly effective birth control or to remain abstinent during the trial and for 30 days after the last dose of IMP. Complete abstinence from sexual intercourse if this is the subject's usual and preferred lifestyle; or sexual partner with surgical sterilization (e.g., tubal ligation, hysterectomy and/or bilateral oophorectomy, vasectomy).

Who cannot join

  • Individuals who do not satisfy the inclusion criteria for Part A (Genetic Screening) will be excluded.
  • Subjects who meet any of the following criteria for Part B (Double-Blind Treatment) are not eligible for the study.
  • The subject has Gaucher's disease (GD), as defined by clinical signs and symptoms (i.e., hepatosplenomegaly, cytopenia, skeletal disease), and/or a medical history of marked deficiency of GCase activity compatible with GD.
  • The subject is homozygous for a GBA1 pathogenic variant that is known to be associated with GD or compound heterozygous for 2 alleles that are known to be associated with GD.
  • The subject carries a known PD-associated LRRK2 pathogenic variant.
  • The subject has atypical or secondary parkinsonism by medical history or in the opinion of the investigator. Atypical parkinsonism includes, but is not limited to, diagnoses of progressive supranuclear palsy, cortico-basal syndrome, and multiple system atrophy. Secondary parkinsonism includes drug-induced, toxin-induced, postinfectious, posttraumatic, or vascular parkinsonism.
Show all 26Show fewer
  • The subject has a history of (within 60 days before initiation of screening) or has planned upcoming major surgery that could interfere with, or for which the treatment might interfere with, the conduct of the study or that would pose an unacceptable risk to the subject in the opinion of the investigator.
  • The subject has any active or chronic disease or condition other than PD that could interfere with, or for which the treatment might interfere with, the conduct of the study or pose an unacceptable risk to the subject in the opinion of the investigator based on medical history, physical examination, vital signs, 12-lead ECG, or clinical laboratory tests. Minor deviations of laboratory values from the normal range may be acceptable if judged by the investigator to have no/minor clinical relevance.
  • The subject has a recent history (last 6 months) of abuse of addictive substances (alcohol, illegal substances), currently uses >21 units of alcohol per week, or is a regular recreational user of sedatives, hypnotics, tranquillizers, or any other addictive agent in the opinion of the investigator.
  • The subject has a positive test for drugs of abuse at screening or before administration of the first dose of investigational medicinal product (IMP) that the investigator judges as clinically relevant. A positive test for tetrahydrocannabinol (THC) is exclusionary. A positive test for cannabinoids (not containing THC) is not exclusionary if the subject is a recreational user (not an abuser) of cannabinoids, in the opinion of the investigator, and agrees to abstain from using cannabinoids within 12 hours before study visits. A positive drug screen that is attributed to an allowed prescription drug is not exclusionary but should be agreed with the medical monitor.
  • The subject is currently pregnant, is planning pregnancy within the timeframe of the study, or is breastfeeding.
  • The subject is using a strong inhibitors and inducers CYP3A4 at the time of screening for Part B (Double-Blind Treatment).
  • The subject is using a breast cancer resistance protein (BCRP) substrate (e.g., pravastatin, rosuvastatin, glyburide) at the time of screening for Part B (Double-Blind Treatment).
  • The subject has used any of the following medications within 60 days before Baseline: typical or atypical antipsychotics (including, but not limited to, clozapine, pimavanserin, olanzapine, risperidone, and aripiprazole), metoclopramide, prochlorperazine, methyldopa, tetrabenazine, deutetrabenazine, valbenazine, or reserpine.
  • The subject has received a vaccination within 14 days before administration of the first dose of IMP.
  • The subject has a prior history of or there is a plan to conduct deep brain stimulation (DBS), lesional procedures, (i.e., thalamotomy), or focused ultrasound; to initiate gene therapy treatment for PD; or to initiate use of any formulation of intestinal infusion or continuous subcutaneous infusion of PD medications.
  • The subject is currently participating in or has participated in an investigational drug study within 3 months or 5 half-lives, whichever is longer; in a therapeutic device study within 3 months before the first dose of IMP; or has previously participated in a gene therapy trial. Concurrent participation in an observational study is acceptable.
  • The subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus 1 (HIV-1) or 2 (HIV-2) at screening. If reflex testing for hepatitis B or HCV DNA is negative, the subject may be eligible for the study.
  • The subject has renal insufficiency as defined by an estimated glomerular filtration rate (eGFR) of <60 mL/min at screening.
  • The subject has cirrhosis (Child-Pugh A, B, or C) or any of the following laboratory values at screening: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN) or bilirubin >2 × ULN except if the subject has known or suspected Gilbert's disease.
  • The subject has a QT interval corrected for heart rate by Fridericia's method (QTcF) value >450 msec if male or >470 msec if female at screening.
  • The subject provides a positive response on Question 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) based on the last 6 months or, in the opinion of the investigator, presents a serious risk of suicide at screening.
  • The subject had a positive severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) test (any type) result within the 30 days before signing informed consent for Part B (Double-Blind Treatment) or has 2 or more current symptoms (e.g., sore throat, cough, fever) at the same time that are consistent with the Coronavirus disease 2019 (COVID-19) infection (not tested) in the opinion of the investigator.
  • The subject has a clinical history that is consistent with a previous COVID-19 infection and has not recovered fully, maintaining nonspecific symptoms like, for example, fatigue, shortness of breath, difficulty concentrating, sleep disorders, fever, anxiety, and depression.
  • The subject has previously received BIA 28-6156 or has a known allergy or hypersensitivity to BIA 28-6156 or any components of the formulation.
  • The subject is an unsuitable candidate to receive BIA 28-6156 or is unable or unlikely to comply with the dosing schedule or study evaluations in the judgment of the investigator.

Trial locations and contacts

95 sites in 11 countries.

95 sites in 11 countries

United States43 sites

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

  • University of Colorado

    Aurora, Colorado, 80045

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Baylor University Medical Center

    Baltimore, Maryland, 21287

  • The Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Parkinson's Center and Movement Disorders of Boca Raton

    Boca Raton, Florida, 33486

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • MUSC

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Quest Research Institute, LLC

    Farmington Hills, Michigan, 48334

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Kansas Medical Center

    Kansas City, Kansas, 66103

  • Evergreen Neuroscience Institute

    Kirkland, Washington, 98034

  • University of California San Diego

    La Jolla, California, 92037

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Cedars-Sinai

    Los Angeles, California, 90048

  • University of Miami, Dept. of Neurology

    Miami, Florida, 33136

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Icahn School of Medicine at Mount Sinai Beth Israel

    New York, New York, 10003

  • Weil Cornell Medical Center

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

  • Northwell Health Physician Partners

    New York, New York, 10075-1851

  • Northwell Health

    New York, New York, 10075

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Parkinson's Disease and Movement Disorders Cente at University of Pennyslvania

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester Neurology

    Rochester, New York, 14642

  • Struthers Parkinson's Center- East

    Saint Paul, Minnesota, 55130

  • Park Nicollet Struther's Parkinson's Center (Struthers Parkinsons Center at HealthPartners)

    Saint Paul, Minnesota, 55427

  • Intermountain Healthcare

    Salt Lake City, Utah, 84107

  • University of Texas Health Science Center - San Antonio

    San Antonio, Texas, 78229

  • University of Washington

    Seattle, Washington, 98195

  • University Hospitals Cleveland Medical Center

    South Euclid, Ohio, 44121

  • Inland Northwest Research

    Spokane, Washington, 99202

  • Univerity of Toledo

    Toledo, Ohio, 43614

Other trials in United States

Italy10 sites

  • IRCCS Istituto Delle Scienze Neurologiche DI

    Bologna

  • Spedali Civilia di Brescia

    Brescia, 25123

  • Ospedale Antonio Perrino

    Brindisi, 72100

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • IRCCS Carlo Besta Neurological Institute

    Milan, 20133

  • Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia I

    Naples, 80138

  • Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Neurologica

    Padova, 35128

  • IRCSS San Raffaele Pisana

    Roma, 163

  • Istituto Clinico Humanitas

    Rozzano, 20086

  • A.O.U. San Giovanni di Dio Ruggi d'Aragona Centro Parkinson- Piano Rialzato Corpo QT

    Salerno, 84125

Other trials in Italy

France7 sites

  • CHU de Nantes - Hopital Nord Laennec

    Nantes

  • CHU de Nice Hopital Pasteur

    Nice, 6002

  • CHU de Nimes

    Nîmes

  • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Pitie-Salpetriere - Centres d'Investigation Clinique (CIC) Paris-Est

    Paris

  • CHU de Rennes Hopital Pontchaillou

    Rennes

  • CIC Toulouse

    Toulouse

  • Hopital Paule de Viguier

    Toulouse

Other trials in France

Germany7 sites

  • Neurologisches Fachkrankenhaus für, Bewegungsstörungen und Parkinson

    Beelitz-Heilstätten, 14547

  • Gertrudis Clinic Biskirchen, Parkinson-Center

    Biskirchen, 35638

  • Paracelsus-Elena-Klinik

    Kassel, 34128

  • Universitats klinikum Marburg

    Marburg, 35039

  • Klinikum der Universität München, Campus Grosshadern, Neurologische Klinik und Poliklinik

    Munich, 81377

  • Ludwig-Maximilians University Munich

    Munich

  • Parkinson-Klinik Ortenau GmbH&Co KG

    Wolfach, 77709

Other trials in Germany

Spain7 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitario Cruces

    Barakaldo, 48903

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 08025

  • Hospital Vall D´Hebron

    Barcelona, 08035

  • Hospital Universitaio de La Princesa

    Madrid, 28006

  • Hospital Ruber Internacional

    Madrid, 28034

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

Portugal5 sites

  • Centro Hospitalar Universitario de Coimbra

    Coimbra

  • Hospital Senhora da Oliveira de Guimaraes

    Guimarães, 4835-044

  • Centro Hospitalar Universitario de Santo Antonio

    Porto, 4099-001

  • Hospital S.JOÃO

    Porto, 4200-319

  • CNS - Campus Neurologico

    Torres Vedras

Other trials in Portugal

United Kingdom5 sites

  • NHS Tayside-Ninewells Hospital and Medical School

    Dundee

  • Glasgow Memory Clinic

    Glasgow

  • King's College London - David Goldberg Centre

    London

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital

    Newcastle upon Tyne

  • University Hospitals Plymouth NHS Trust

    Plymouth

Other trials in United Kingdom

Canada3 sites

  • Clinique Neuro-Outaouais (Neuro-Outaouais Clinic)

    Gatineau, Quebec

  • Montreal Neurological Institute & Hospital

    Montreal, Quebec, 3801

  • Ottawa Hospital Research Institute

    Ottawa

Other trials in Canada

Netherlands3 sites

  • Amsterdam Medical Center UMC

    Amsterdam

  • University Medical Center Groningen

    Groningen

  • St. Antonius Ziekenhuis (St. Antonius Hospital) - Utrecht

    Utrecht

Other trials in Netherlands

Poland3 sites

  • Centrum Medyczne NEUROMED Sp. z o.o. ul.

    Bydgoszcz, 85-163

  • Krakowkska Akademia Neurologii Sp. z o.o

    Krakow, 31-505

  • NeuroKlinika Gabinet Lekarski

    Lodz, 90-640

Other trials in Poland

Sweden2 sites

  • Skane University Hospital, Lund University

    Lund, 221 85

  • Neurologmottagningen, QD 62

    Uppsala

Other trials in Sweden

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in Subjects With Parkinson's Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene

The purpose of this randomized, double-blind, placebo-controlled study is to assess the efficacy of BIA 28-6156 over placebo in delaying clinical meaningful motor progression over 78 weeks in subjects with Parkinson's disease who have a pathogenic variant in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).

Read the detailed description

This is a 2-part (Part A [Genetic Screening] and Part B [Double-Blind Treatment]), Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of 2 fixed dose levels of BIA 28-6156 (10 and 60 mg/day) in approximately 237 subjects with genetically confirmed GBA-PD.

Part A (Genetic Screening) will identify individuals with a PD risk-associated variant in the GBA1 gene for potential enrolment into Part B (Double-Blind Treatment) of the study. Part B will consist of a screening period to ensure that all protocol inclusion/exclusion criteria for Part B of the study are met (up to 5 weeks). After screening period, eligible subjects will be randomized into 1 of 3 treatment arms (BIA 28-6156 10 mg/day, BIA 28-6156 60 mg/day, or placebo) in a 1:1:1 ratio, and enter a double-blind treatment period up to 78 weeks, followed by a 30-day (4 weeks) of safety follow-up period.

Subjects must be receiving a stable dose of PD medication for at least 30 days before screening (for Part B [Double-Blind Treatment]) and will continue to receive their usual PD medications throughout the study.

Being tested
BIA 28-6156 10 mg, BIA 28-6156 60 mg, Placebo
Keywords
Parkinson Disease, Neurodegenerative Diseases, Central Nervous System Diseases, Glucocerebrosidase (GCase) activity, Parkinsonian Disorders, Basal Ganglia Diseases, Movement Disorders, GBA1 gene, BIA 28-6156, Phase 2
Medical subject headings
Parkinson Disease, Neurodegenerative Diseases, Central Nervous System Diseases, Motor Activity, Parkinsonian Disorders, Basal Ganglia Diseases, Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIA 28-6156 10 mgDrug

    BIA 28-6156 10 mg, once daily, oral administration.

  • BIA 28-6156 60 mgDrug

    BIA 28-6156 60 mg, once daily, oral administration.

  • PlaceboDrug

    Placebo, once daily, oral administration.

Study groups in NCT05819359
Study groupRoleWhat they receive
BIA 28-6156 10 mgExperimentalParticipants will be randomized to receive BIA 28-6156 10 mg during the Treatment Period.
Receives: Drug: BIA 28-6156 10 mg
BIA 28-6156 60 mgExperimentalParticipants will be randomized to receive BIA 28-6156 60 mg during the Treatment Period.
Receives: Drug: BIA 28-6156 60 mg
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from baseline to clinically meaningful progression on motor aspects of experiences of daily living (assessed by MDS-UPDRS Part II score and MDS-UPDRS Part III score)

    Time from baseline to clinically meaningful progression on motor aspects of experiences of daily living, as assessed by ≥2-point increase from baseline in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score and no improvement in the Motor Examination, as assessed by ≥0-point increase from baseline in MDS-UPDRS Part III score. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assesses motor experiences of daily living (Range 0-52). It contains 13 questions which are to be rated by the patient and/or caregiver. Part III assesses the motor signs of PD and is rated by the investigator (Range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicates more severe symptoms of PD.

    Measured: From Baseline up to Week 78

Secondary outcomes (6)

  1. Time from baseline to clinically meaningful progression on motor signs of the disease (assessed by MDS-UPDRS Part III score)

    Time from baseline to clinically meaningful progression on motor signs of the disease, as assessed by a ≥5-point increase from baseline in the MDS-UPDRS Part III score. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part III assesses the motor signs of PD and is rated by the investigator (Range 0-132). Part III contains 33 scores based on 18 items. A higher score indicates more severe symptoms of PD.

    Measured: From Baseline up to Week 78

  2. Time from baseline to any worsening on the Clinical Global Impression - Change (CGI-C) scale

    The Clinical Global Impression of Change (CGI-C) is a scale used to assess the overall clinical improvement or worsening of a patient's condition over time. The CGI-C scale ranges from 1 to 7, with lower scores indicating greater improvement (1 - Very much improved, 2 - Much improved, 3 - Minimally improved, 4 - No change, 5 - Minimally worse, 6 - Much worse, 7 - Very much worse).

    Measured: From Baseline up to Week 78

  3. Time from baseline to any worsening on the Patient Global Impression - Change (PGI-C) scale

    The Patient Global Impression of Change (PGI-C) is a self-report tool used to assess a patient's perception of their overall improvement or worsening in a particular health-related domain over time. The PGI-C scale asks patients to rate their overall improvement or worsening since the start of treatment on a seven-point scale, with lower scores indicating greater improvement (1 - Very much improved, 2 - Much improved, 3 - Minimally improved, 4 - No change, 5 - Minimally worse, 6 - Much worse, 7 - Very much worse)

    Measured: From Baseline up to Week 78

  4. Change from Baseline to Week 78 in the MDS-UPDRS Total (Part I-IV) score

    The MDS-UPDRS assesses nonmotor and motor experiences of daily living, motor examination, and motor complication categories. The MDS-UPDRS Part I-IV total score was calculated as the sum of the individual item scores from these categories. Each item is rated on a scale from 0 to 4 on which 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. A higher score indicates more severe symptoms of PD.

    Measured: From Baseline up to Week 78

  5. Change from Baseline to Week 78 in the Modified Hoehn and Yahr score

    The Modified Hoehn and Yahr scale measures the severity of Parkinson's disease by assessing the patient's motor symptoms and functional impairment. The scale has seven stages, ranging from 1 to 5, with higher scores indicating more severe disease. (1 - Unilateral involvement only; 1.5 - Unilateral and axial involvement; 2 - Bilateral involvement without impairment of balance; 2.5 - Mild bilateral disease with recovery on pull test; 3 - Mild to moderate bilateral disease; some postural instability; physically independent; 4 - Severe disability; still able to walk or stand unassisted; 5 - Wheelchair bound or bedridden unless added).

    Measured: From Baseline up to Week 78

  6. Change from Baseline to Week 78 in the 39-Item Parkinson's Disease Questionnaire (PDQ-39) score

    The PDQ-39 is the most thoroughly validated and extensively used self-report measure for the assessment of health-related quality of life in patients with PD. The questionnaire measures 39 items, which assess 8 domains of health: mobility (10 items), activities of daily living (6 items), emotional well being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), and bodily discomfort (3 items). Each item is scored on the following scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = always. Items in each subscale and the total scale can be summarized into an index and transformed linearly to a scale from 0 (perfect health as assessed by the measure) to 100 (worst health as assessed by the measure).

    Measured: From Baseline up to Week 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2023
  2. Study start31 Mar 2023
  3. Primary completion2 Apr 2026
  4. Study completion9 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05819359
Sponsor's protocol ID
BIA 28-6156-201
Other IDs
2022-501783-18-00
Acronym
ACTIVATE
Status last verified
Nov 2026
First submitted
6 Apr 2023
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIA 28-6156 10 mg and BIA 28-6156 60 mg in people with Parkinson's Disease, run by Bial R&D Investments, S.A. at 95 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Italy, France, Germany, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from baseline to clinically meaningful progression on motor aspects of experiences of daily living (assessed by MDS-UPDRS Part II score and MDS-UPDRS Part III score) (time frame: From Baseline up to Week 78). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05819359.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in