Study on BIA 28-6156 for Parkinson’s Disease in Patients with GBA1 Gene Variant

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What is this study about?

This clinical trial is focused on studying Parkinson’s Disease, a condition that affects movement and can cause tremors, stiffness, and difficulty with balance and coordination. The study is investigating a new treatment called BIA 28-6156, which is an allosteric activator of the enzyme beta-glucocerebrosidase (GCase). This enzyme is important for breaking down certain substances in the body, and the treatment aims to help manage symptoms in people with Parkinson’s Disease who have a specific genetic variant in the GBA1 gene.

The purpose of the study is to evaluate how effective BIA 28-6156 is in slowing down the progression of motor symptoms in individuals with this genetic variant. Participants in the study will be randomly assigned to receive either the treatment or a placebo, which looks like the treatment but does not contain the active substance. The study will be conducted over a period of time, during which participants will take the medication in the form of a film-coated tablet by mouth. The study will monitor the safety and tolerability of the treatment, as well as how it is processed by the body.

Throughout the study, participants will be assessed using a scale called the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), which helps measure the severity of motor symptoms. The study aims to determine if BIA 28-6156 can delay the worsening of these symptoms compared to the placebo. This research is important for understanding potential new treatments for Parkinson’s Disease, especially for those with the GBA1 gene variant.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the investigational medication BIA 28-6156 or a placebo. A placebo is a substance with no active medication, used to compare the effects of the investigational drug.

2 medication administration

If you are assigned to the BIA 28-6156 group, you will take the medication in the form of a film-coated tablet. The medication is taken orally, meaning you will swallow the tablet with water.

The dosage, frequency, and duration of administration will be provided by the study team. It is important to follow the instructions carefully to ensure the accuracy of the study results.

3 monitoring and assessments

Throughout the study, your health and the effects of the medication will be closely monitored. This includes regular assessments of your motor skills and daily living activities using a scale called the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).

You will be required to use a smartphone application and wear a smartwatch to measure Parkinson’s disease-related motor signs. This helps in tracking your progress and any changes in your condition.

4 completion of the study

The study is expected to continue until June 2026. Upon completion, you will have a final assessment to evaluate the overall effects of the medication.

Your participation will contribute to understanding the efficacy and safety of BIA 28-6156 in treating Parkinson’s disease with a specific genetic variant.

Who Can Join the Study?

  • The person is between 35 and 80 years old.
  • The person has been diagnosed with Parkinson’s Disease for at least 1 year but not more than 7 years.
  • The person has a GBA1 gene variant linked to Parkinson’s Disease, as determined by genetic screening in the study.
  • The person is receiving treatment to help with Parkinson’s Disease symptoms.
  • The person can understand and sign a consent form, which explains the study’s purpose, risks, and requirements.
  • The person has a score of 2.5 or less on the Hoehn and Yahr scale, which measures the severity of Parkinson’s Disease.
  • The person has a score of 22 or higher on the MoCA scale, a test that checks thinking and memory skills.
  • The person does not have moderate motor complications, as shown by a score of less than 3 on certain parts of the MDS-UPDRS Part IV, a scale that measures movement issues.
  • The person does not have significant psychosis, which means they do not have severe mental health issues like hallucinations or delusions.
  • The person has been on stable doses of Parkinson’s Disease medications for at least 30 days (or 60 days for a medication called rasagiline) before starting the study.
  • The person is willing and able to use a smartphone app and wear a smartwatch to track Parkinson’s Disease-related movement signs during the study.
  • The person has a Body Mass Index (BMI) between 18 and 40. BMI is a measure of body fat based on height and weight.
  • If the person is sexually active and can have children, they agree to use highly effective birth control methods or remain abstinent during the study and for 30 days after the last dose of the study medication.

Who Cannot Join the Study?

  • Patients who do not have a confirmed diagnosis of Parkinson’s Disease with a specific genetic variant in the GBA1 gene cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Karolinska University Hospital Solna Sweden
Hospital Universitario De Cruces Barakaldo Spain
Centre Hospitalier Universitaire De Nice Nice France
Azienda Sanitaria Locale Di Taranto Taranto Italy
Kliniken Beelitz GmbH Beelitz Germany
Virgen del Rocío University Hospital Sevilla Spain
Irccs San Raffaele Roma S.r.l. Rome Italy
Centre Hospitalier Universitaire De Nantes Nantes France
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Centre Hospitalier Universitaire De Nimes Nimes France
St. Antonius Ziekenhuis Utrecht The Netherlands
Hospital Ruber Internacional Madrid Spain
Universita Degli Studi Di Brescia Brescia Italy
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA Kassel Germany
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz Poland
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona Salerno Italy
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
CNS Saude Lda. Torres Vedras Portugal
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Gertrudis Klinik Biskirchen Leun Germany
Hopital Purpan Toulouse France
Hôpital Pontchaillou-CHU Rennes Rennes France
Aqrzfbg Uzdhr Sfnwhwnna Liwqjp Dl Biwexjl Bologna Italy
Udblbjbgidjyujjndpzum Grqtjqb ufm Mnsuoug Gxuw Marburg Germany
Ajscrcokl Ugn Amsterdam The Netherlands
Kotdnyob dhr Ubitxrfniwea Mlkgscrq Aiv Munich Germany
Hmuzztdf Dt Ld Skbbu Cmit I Sfpi Pty Barcelona Spain
Hasaculb Ucbamdtckqdpd Di Li Pdvzkkhu Madrid Spain
Uwkbptmidk Huantkbtn Pjifo Sjygkjgwbcv Croqhae Fvkn Paris France
Hvwninyg Uiruwajjmdlts Hhdygqsb Tbrys y Pjxcaw Ikazpgbk Ceckal dflehzzqrsofljmiv (njdn Badalona Spain
Hrmmvuhy Voug dcigexjt Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
01.09.2023
Germany Germany
Not recruiting
01.09.2023
Italy Italy
Not recruiting
01.09.2023
Poland Poland
Not recruiting
01.09.2023
Portugal Portugal
Not recruiting
01.09.2023
Spain Spain
Not recruiting
01.09.2023
Sweden Sweden
Not recruiting
01.09.2023
The Netherlands The Netherlands
Not recruiting
01.09.2023

Trial locations

BIA 28-6156 is a medication being studied for its potential to help people with Parkinson’s disease, specifically those who have a certain genetic variant known as GBA1. This medication is being tested to see if it can slow down the worsening of movement problems that are common in Parkinson’s disease. The study aims to find out if BIA 28-6156 can make a difference in how quickly these movement issues progress, which could improve the quality of life for people with this condition. The medication is being evaluated for its effectiveness, safety, and how well people can tolerate it.

Investigated diseases:

Parkinson’s Disease – Parkinson’s Disease is a progressive neurological disorder that affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. The disease progresses gradually, often starting with barely noticeable tremors in one hand. As it advances, individuals may experience slowness of movement, muscle rigidity, and impaired posture. Over time, the symptoms can become more severe, affecting daily activities and leading to difficulties in walking and talking. The progression of Parkinson’s Disease varies among individuals, with some experiencing a slow progression and others a more rapid decline in motor function.

Trial ID:
2022-501783-18-00
Protocol code:
BIA 28-6156-201
NCT ID:
NCT05819359
Trial Phase:
Therapeutic exploratory (Phase II)

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