BIA 28-6156 for Parkinson's Disease

(ACTIVATE Trial)

Not currently recruiting at 138 trial locations

Overseen By Rodolfo Savica

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must be taking: PD medications

Must not be taking: Antipsychotics, Metoclopramide, Methyldopa, others

Disqualifiers: Gaucher's disease, LRRK2 variant, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BIA 28-6156, a potential drug, to determine if it can slow the progression of movement problems in people with Parkinson's disease who have a specific genetic variant. Participants will receive either 10 mg or 60 mg of BIA 28-6156, or a placebo, which resembles the treatment but contains no active ingredient, to compare effects. Individuals who have had Parkinson's disease for at least one year, with stable symptoms and no severe motor issues, might be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that participants have been on stable doses of Parkinson's disease medications for at least 30 days (60 days for rasagiline) before starting the study. However, you cannot use certain medications like strong CYP3A4 inhibitors or inducers, BCRP substrates, or specific antipsychotics within 60 days before the trial.

Is there any evidence suggesting that BIA 28-6156 is likely to be safe for humans?

Research has shown that BIA 28-6156 was well-tolerated in earlier studies. In one study, participants with Parkinson's disease linked to the GBA1 gene took it daily for 28 days without major side effects. As BIA 28-6156 is in the middle stage of testing, the treatment has demonstrated a good safety record in initial trials, but further information is being gathered to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's disease?

Researchers are excited about BIA 28-6156 for Parkinson's disease because it offers a fresh approach compared to current treatments like levodopa and dopamine agonists. Unlike these standard therapies that primarily aim to replenish dopamine levels, BIA 28-6156 may have a novel mechanism of action that targets underlying pathways of the disease. This could potentially slow disease progression rather than just alleviate symptoms. Additionally, having different dosage options, such as 10 mg and 60 mg, allows for flexibility in treatment, which could lead to more personalized care.

What evidence suggests that BIA 28-6156 might be an effective treatment for Parkinson's disease?

Researchers are investigating BIA 28-6156 to determine if it can slow the progression of movement problems in people with Parkinson's disease who have a specific genetic variant. The trial will compare two doses of BIA 28-6156, 10 mg and 60 mg, with a placebo to assess its effectiveness. This treatment targets the GBA1 gene, which is linked to Parkinson's when altered. Although detailed results are not yet available, the goal is to see if BIA 28-6156 can delay the decline in movement abilities. Early studies in healthy individuals showed no major changes in certain cell markers, indicating the need for further research to understand its effects on people with Parkinson's. This trial aims to provide clearer information about its efficacy. ^{1 3 4 5 6}

Who Is on the Research Team?

Raquel Costa

Principal Investigator

Bial R&D Investments, S.A.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion 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.

Timeline for a Trial Participant

Genetic Screening

Identify individuals with a PD risk-associated variant in the GBA1 gene for potential enrolment

Not specified

Screening

Participants are screened for eligibility to participate in the trial

Up to 5 weeks

Double-Blind Treatment

Participants receive BIA 28-6156 or placebo to assess efficacy, safety, and tolerability

78 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BIA 28-6156
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: BIA 28-6156 60 mg Experimental Treatment 1 Intervention

Participants will be randomized to receive BIA 28-6156 60 mg during the Treatment Period.

Group II: BIA 28-6156 10 mg Experimental Treatment 1 Intervention

Participants will be randomized to receive BIA 28-6156 10 mg during the Treatment Period.

Group III: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Bial R&D Investments, S.A.

Lead Sponsor

Trials

2

Recruited

240+

Published Research Related to This Trial

COMT inhibitors have been shown to effectively prolong the action of levodopa in Parkinson's disease patients experiencing the 'wearing off' phenomenon, providing a new treatment option for those with fluctuating responses to standard therapy.

Clozapine not only alleviates levodopa-induced psychosis but also helps reduce tremors and dyskinesias, highlighting its dual role in managing symptoms of Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New medical and surgical treatments for Parkinson's disease. Klockgether, T., Löschmann, PA., Wüllner, U.[2019]

Motor fluctuations and dyskinesias are common and debilitating complications in Parkinson's disease patients within the first few years of treatment, significantly impacting their quality of life.

New therapeutic options, such as subcutaneous apomorphine and deep-brain stimulation, are available for patients who continue to experience motor complications despite optimal medical management, potentially improving both motor and nonmotor symptoms of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of motor complications in Parkinson disease: current and emerging therapies. Espay, AJ.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05819359

Study Details | NCT05819359 | Efficacy, Safety, Tolerability ... 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 ...

2. firstwordpharma.com firstwordpharma.com/story/6229644

Key Milestone in ACTIVATE Phase 2 Clinical Trial of BIA ... This brings us closer to obtaining the data needed to rigorously assess the safety and efficacy of BIA 28-6156, which could become a much-needed ...

3. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.29346

A Phase 1B Trial in GBA1‐Associated Parkinson's Disease of ... In an earlier study of LTI-291/BIA-28-6156 in healthy elders, intracellular GluCer isomers (in PBMCs) did not change significantly over 14 days ...

4. neurologylive.com neurologylive.com/view/first-patient-dosed-phase-2-activate-trial-bia-28-6156-parkinson-disease

First Patient Dosed in Phase 2 ACTIVATE Trial of BIA 28- ... The phase 2 clinical trial ACTIVATE investigating BIA 28-6156 for Parkinson disease is currently screening for patients in North America and with the Europe- ...

5. parkinsonsnewstoday.com parkinsonsnewstoday.com/news/trial-bia-28-6156-gba1-parkinsons-patients-hits-milestone/

Trial of BIA 28-6156 for GBA1 Parkinson's patients hits ... The study, called ACTIVATE (NCT05819359), is assessing the treatment's safety and efficacy at slowing the clinical progression of motor symptoms ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37195859/

A Phase 1B Trial in GBA1-Associated Parkinson's Disease ... These first-in-patient studies demonstrated that LTI-291 was well tolerated when administered orally for 28 consecutive days to patients with GBA-PD.