237 Participants Needed

BIA 28-6156 for Parkinson's Disease

(ACTIVATE Trial)

Recruiting at 130 trial locations
CP
DN
MT
HP
SF
TL
RM
RS
Overseen ByRodolfo Savica
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Bial R&D Investments, S.A.
Must be taking: PD medications
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

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.12345

Who Is on the Research Team?

RC

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.
See 12 more

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.
See 23 more

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?
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 Clinic Near You

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

Citations

Normalization of GABAA receptor specific binding in the substantia nigra reticulata and the prevention of L-dopa-induced dyskinesias in MPTP parkinsonian monkeys. [2016]
A multicenter randomized controlled trial of remacemide hydrochloride as monotherapy for PD. Parkinson Study Group. [2019]
A randomized, controlled trial of remacemide for motor fluctuations in Parkinson's disease. [2019]
New medical and surgical treatments for Parkinson's disease. [2019]
Management of motor complications in Parkinson disease: current and emerging therapies. [2013]
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