BIA 28-6156 for Parkinson's Disease

(ACTIVATE Trial)

Recruiting at 130 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

237 Participants Needed

Trial Summary

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.

What makes the drug BIA 28-6156 unique for Parkinson's disease?

BIA 28-6156 may be unique in its approach to treating Parkinson's disease by potentially targeting the glutamatergic system, which is different from traditional treatments that primarily focus on the dopaminergic system. This could help manage symptoms and complications like motor fluctuations by modulating glutamate activity. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new drug called BIA 28-6156 to see if it can slow down movement problems in people with Parkinson's disease who have a specific genetic mutation. The study will compare the drug to another treatment over a period of several months.

Research Team

Raquel Costa

Principal Investigator

Bial R&D Investments, S.A.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Normalization of GABAA receptor specific binding in the substantia nigra reticulata and the prevention of L-dopa-induced dyskinesias in MPTP parkinsonian monkeys. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

A multicenter randomized controlled trial of remacemide hydrochloride as monotherapy for PD. Parkinson Study Group. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial of remacemide for motor fluctuations in Parkinson's disease. [2019]

4. England pubmed.ncbi.nlm.nih.gov

New medical and surgical treatments for Parkinson's disease. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

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