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Enzyme Inhibitor
BIA 28-6156 for Parkinson's Disease (ACTIVATE Trial)
Verified Trial
Phase 2
Recruiting
Research Sponsored by Bial R&D Investments, S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- The subject is ≥35 and ≤80 years of age at the time of informed consent.
- The subject has a modified Hoehn and Yahr score ≤2.5.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to week 78
Awards & highlights
ACTIVATE Trial Summary
This trial tests a drug to slow motor decline in Parkinson's patients with a certain gene mutation.
Who is the study for?
This trial is for adults aged 35-80 with Parkinson's disease (PD) diagnosed between 1 and 7 years, carrying a specific GBA1 gene variant but not Gaucher's disease. They must have mild to moderate PD severity, stable PD medication use, no severe motor issues or surgery plans that could affect the study, and agree to birth control if applicable. Excluded are those with atypical parkinsonism, substance abuse history, certain medical conditions or treatments that might interfere with the study.Check my eligibility
What is being tested?
The trial tests BIA 28-6156 (10 mg or 60 mg) against a placebo in delaying motor progression over 78 weeks in patients with GBA-PD. It's randomized and double-blind meaning neither participants nor researchers know who receives the drug or placebo during the study.See study design
What are the potential side effects?
While specific side effects of BIA 28-6156 aren't listed here, common clinical trial risks may include allergic reactions to components of the drug formulation, general discomforts like headaches or nausea related to medication intake.
ACTIVATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 35 and 80 years old.
Select...
My Parkinson's disease is in the early or mid-stage.
Select...
I am currently receiving treatment for Parkinson's disease symptoms.
Select...
I have a genetic variant linked to Parkinson's disease.
ACTIVATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to week 78
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to week 78
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
Secondary outcome measures
Change from Baseline to Week 78 in the 39-Item Parkinson's Disease Questionnaire (PDQ-39) score
Change from Baseline to Week 78 in the MDS-UPDRS Total (Part I-IV) score
Change from Baseline to Week 78 in the Modified Hoehn and Yahr score
+3 moreACTIVATE Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: BIA 28-6156 60 mgExperimental Treatment1 Intervention
Participants will be randomized to receive BIA 28-6156 60 mg during the Treatment Period.
Group II: BIA 28-6156 10 mgExperimental Treatment1 Intervention
Participants will be randomized to receive BIA 28-6156 10 mg during the Treatment Period.
Group III: PlaceboPlacebo Group1 Intervention
Placebo
Find a Location
Who is running the clinical trial?
Bial R&D Investments, S.A.Lead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
Luís M Magalhães, PharmDStudy DirectorBial R&D Investments, S.A.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Gaucher's disease, confirmed by symptoms or tests showing low GCase activity.I have a form of parkinsonism that is not typical Parkinson's disease.I have had or will have major surgery that could affect my participation in the study.I have not tested positive for drugs, except for THC or prescribed medications.I am not using strong CYP3A4 inhibitors or inducers currently.I am currently taking medication like pravastatin or rosuvastatin.I have had or am planning to have advanced treatments for Parkinson's disease.My kidney function is reduced with an eGFR below 60 mL/min.I tested positive for COVID-19 or have symptoms like sore throat, cough, and fever recently.I am allergic or have had a reaction to BIA 28-6156.I meet all the requirements for the genetic screening part of the study.I am between 35 and 80 years old.My Parkinson's disease is in the early or mid-stage.I have been on a stable dose of my Parkinson's medication for over a month.I have a genetic mutation linked to Gaucher's disease.I tested positive for HBsAg, anti-HCV, or HIV but may still qualify if further tests for hepatitis B or C are negative.I am able to understand and sign the consent form.I have a genetic variant linked to Parkinson's disease.I am able to understand and sign the consent form.I am currently receiving treatment for Parkinson's disease symptoms.I have been diagnosed with Parkinson's disease for 1 to 7 years.I have a genetic mutation linked to Parkinson's disease.I did not meet the genetic screening requirements for Part A.I have not taken certain mental health or movement disorder medications in the last 60 days.I haven't been in a drug or device study recently, nor have I ever been in a gene therapy trial.I have cirrhosis or my liver tests are higher than normal.I had COVID-19 and still experience symptoms like fatigue or difficulty concentrating.
Research Study Groups:
This trial has the following groups:- Group 1: BIA 28-6156 10 mg
- Group 2: BIA 28-6156 60 mg
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the upper age limit for participants in this trial greater than seventy-five?
"As per the trial's eligibility requirements, individuals aged 35 to 80 may take part in this study."
Answered by AI
Are there numerous facilities in Canada involved with this research endeavor?
"This clinical trial is running in 73 locations across the nation, such as Aurora, Boca Raton and Ocala. It may be beneficial to choose a site close by so you can minimize travel if accepted into the study."
Answered by AI
For whom is this medical study available?
"To meet the requirements of this clinical trial, participants should have been diagnosed with Parkinson's disease and be between 35-80 years old. This experiment is seeking 237 individuals in total."
Answered by AI
How many volunteers are contributing to this clinical research?
"In order to begin this trial, 237 individuals who fulfil the qualifications must be enrolled. These potential participants can travel to either University of Colorado in Aurora, CO or Parkinson's disease and Movement Disorders Center of Boca Raton in Boca Raton, FL."
Answered by AI
What potential hazards are associated with the ingestion of BIA 28-6156 10 mg?
"Having assessed the data available, our team at Power rated BIA 28-6156 10 mg with a 2: there is some research indicating its safety but no evidence of efficacy."
Answered by AI
Is it still possible for patients to join this clinical investigation?
"According to the clinicaltrials.gov listings, this trial was first made available on March 31st 2021; it has remained open for recruitment with a recent update being posted on April 18th of 2021."
Answered by AI
Who else is applying?
What site did they apply to?
Rutgers Robert Wood Johnson Medical School
Mount Sinai Beth Israel
Columbia University Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I wish to regain control over my right leg (I have gaint issues).
PatientReceived no prior treatments
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