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Study on the Safety and Effects of BIIB122 for Patients with LRRK2-Associated Parkinson's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Parkinson's disease, specifically a type associated with a genetic mutation known as LRRK2. The study will evaluate a treatment called BIIB122, which is a tablet taken orally. Participants in the study will either receive the BIIB122 treatment or a placebo, which is a substance with no active medication. The purpose of the study is to assess the safety and effects of BIIB122 in individuals with LRRK2-associated Parkinson's disease.

During the study, participants will be randomly assigned to receive either BIIB122 or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not influenced by expectations. The study will last for a period of 12 weeks, during which the safety and effects of the treatment will be closely monitored.

The main focus will be on observing any side effects and changes in specific biological markers related to Parkinson's disease. These markers include changes in certain proteins in the blood and urine. The study aims to provide valuable information on how BIIB122 affects individuals with LRRK2-associated Parkinson's disease, potentially leading to better treatment options in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed through genetic testing to verify the presence of a pathogenic LRRK2 variant. This is necessary for participation in the trial focused on LRRK2-associated Parkinson's disease.
Step 2
Randomization and treatment assignment
Participants are randomly assigned to receive either the study medication, BIIB122, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
Step 3
Medication administration
The study medication, BIIB122, is provided in tablet form for oral use. The exact dosage and frequency are determined by the study protocol and are administered over a 12-week period.
Step 4
Monitoring and assessments
Throughout the 12-week period, participants undergo regular monitoring to evaluate the safety and effects of the treatment. This includes tracking any adverse events and changes in specific biomarkers related to Parkinson's disease.
Step 5
Completion of treatment period
At the end of the 12-week treatment period, final assessments are conducted to compare the effects of BIIB122 with the placebo. This includes measuring changes in blood and urine markers from the baseline.

Who can join the trial?

5 criteria

Participants must be between 30 and 80 years old if they have one copy of the changed LRRK2 gene. If they have two copies, they must be at least 30 years old.
Participants must have a clinical diagnosis of Parkinson's disease that meets specific criteria set by experts in movement disorders.
Participants must have genetic test results that confirm they have a specific change, called a pathogenic variant, in the LRRK2 gene.
Both men and women can participate in the study.
The study is not open to vulnerable populations, which means people who might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Clinic De Barcelona
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Barcelona, Spain
Hospital Universitari General De Catalunya
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Sant Cugat Del Valles, Spain
Hospital Universitario De La Princesa
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Madrid, Spain

Trial locations

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Investigated drugs

BIIB122 is a medication being studied for its effects on Parkinson's Disease associated with the LRRK2 gene. The trial aims to assess how safe and tolerable this medication is for participants. It is being tested to see if it can help manage symptoms or slow the progression of this specific type of Parkinson's Disease.

N2-(3-(2-(2H-1,2,3-Triazol-2-Yl)Propan-2-Yl)-1-Cyclopropyl-1H-Pyrazol-5-Yl)-N4-Ethyl-5-(Trifluoromethyl)Pyrimidine-2,4-Diamine

What is already known about the treatment

BIIB122 – BIIB122 is an investigational medication currently being studied for its potential use in treating Parkinson's disease, specifically in patients with a genetic mutation known as LRRK2. It is administered orally in the form of tablets. The medication is in the clinical trial phase, with ongoing research to assess its safety and effects on the body. BIIB122 is believed to work by inhibiting the activity of the LRRK2 protein, which is thought to play a role in the progression of Parkinson's disease. It falls under the pharmacological classification of kinase inhibitors, targeting specific enzymes involved in cellular processes.

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 occurs when nerve cells in the brain that produce dopamine become impaired or die. As the condition progresses, symptoms may worsen, leading to increased difficulty in performing daily activities. Non-motor symptoms such as sleep disturbances, mood changes, and cognitive impairment can also occur. The progression of symptoms varies from person to person.