A clinical trial to evaluate the safety of NLRP3i (inhibitor of a protein called NLRP3) and how it affects the body and brain of people living with early-stage Parkinson’s disease.

  • STATUS
    Recruiting
  • End date
    Jul 15, 2023
  • participants needed
    48
  • sponsor
    F. Hoffmann-La Roche Ltd
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Updated on 16 June 2022
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cancer
levodopa
dementia
brain stimulation
alpha-synuclein

Summary

This is a Phase 1b study conducted in the US, the UK, and the Netherlands and aiming to better understand the safety of an oral drug in a capsule form which includes a substance called NLRP3 inhibitor. The study aims to understand how the NLRP3 inhibitor affects the body and brain of people with Parkinson’s disease. The NLRP3 inhibitor drug tested in this study has been studied in healthy participants previously and showed a favorable safety profile, however, it will be the first time it will be studied in people with Parkinson’s disease. 

Description

Parkinson’s disease is a chronic disease of the nervous system (mostly the brain) that gets worse over time. Currently available treatments mainly address common symptoms and not the cause of Parkinson’s disease progression.

Some evidence suggests that people with Parkinson’s disease may have more inflammation in the brain, which may be one of the reasons why Parkinson's disease gets worse over time.

A key component of this inflammation is a protein called NLRP3. Our investigational drug blocks this component, the NLRP3, which could potentially slow the progression of Parkinson’s disease. A drug that blocks chemical reactions, like our investigational drug, is called an inhibitor.

This is a ‘placebo-controlled’ clinical trial, which means that 33% of the participants  [i.e. equal to 1 in 3] will be given a substance with no active ingredients, also known as a ‘placebo’, that looks like the drug being tested. Comparing results from the different groups helps the researchers know whether any changes seen are a result of the drug or occuring by chance. 

Participants will be given the investigational drug or placebo for about 4 weeks. Participants will be seen by the clinical trial doctor every 7 days during the treatment phase [“study visits”] and 2 weeks after the last treatment dose was taken (please refer to timeline visual). These study visits will include checks to see how participants are tolerating the treatment and any side effects they may be having. The visits will also check to see how the investigational drug affects the body and brain of the participants by using advanced brain imaging scans and other tests. Participants’ total time in the clinical trial will be about 3 months and include about 11 study visits. Study visits will take a few hours to a maximum of half a day. Participants will go home between the study visits but can optionally stay in a hotel nearby after pre-defined longer study visits. Participants are free to stop the treatment with the investigational drug and leave the clinical trial at any time. This will not impact their medical care outside of the trial.

Participants will be reimbursed for their travel expenses and their time in the study according to local regulations and considerations.

Details
Condition Parkinson's disease, parkinson disease, Parkinson's Disease
Clinical Study IdentifierTX285556
SponsorF. Hoffmann-La Roche Ltd
Last Modified on16 June 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 50-85 years; male and post menopausal females
_
Diagnosed with Parkinson's disease at least 3 months ago and no more than 3 years ago
SARS-CoV-2 vaccination completed at least 60 days prior to the first dose of the investigational drug. The vaccination has to be complete as per local regulations
Able to swallow capsules whole
_Either_ taking levodopa for at least three months _or_ never started any therapy for controlling PD symptoms
For participants without treatment: No anticipated need to start symptomatic Parkinson's disease therapy for the duration of the study
Agree to reduce the use of tobacco and alcohol products to a minimum throughout the study and to refrain from using tobacco or alcohol during study visits
Fluent in the language of the Investigator and study staff, and able to communicate with the study staff
For participants on stable levodopa treatment: No anticipated need to change treatment for the duration of the study
Body weight ranging from 45-110 kg (99-242 lbs.) and a body mass index (BMI) of 18-32 kg/m2 inclusive
A female participant can participate in the study if she has gone through menopause (i.e., the time in a woman's life when she has been at least 12 months without a menstrual period)
_
For male participants: with a partner who is of childbearing potential or pregnant, agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom. Refrain from donating sperm
_
_Exclusion Criteria:_
Known carriers for mutations in the following genes: alpha-synuclein, LRRK2, GBA, PRKN, PINK1, or DJ1
Disease of the central nervous system (other than Parkinson's disease), for example Stroke, Dementia, Epilepsy
Previous brain surgery for Parkinson's disease (including deep brain stimulation [DBS])
Presence of any psychiatric condition, for example schizophrenia
History of cancer, except for appropriately treated, non-melanoma skin carcinoma, non-metastatic prostate cancer, treated carcinoma in situ of the cervix or Stage I uterine cancer
Major vascular surgery within the last 6 months
Autoimmune diseases
Chronic liver diseases
Uncontrolled hypertension
Immunodeficiency diseases, e.g. HIV
Hepatitis B or C
Vaccine(s) other than SARS-CoV2 vaccine within 28 days prior to the first dose, or plans to receive vaccines during the study or within 28 days of the last dose
Enrollment in another investigational study
Drug and/or alcohol abuse within the last 12 months
Resident of a nursing home or assisted care facility
Donation or loss of blood over 500 mL within 90 days prior to baseline. Plasma donation of 150 mL or more within 7 days prior to baseline
Any contradictions to obtaining a brain MRI or TSPO-PET (e.g., claustrophobia, metal devices or implants, metal deposited in the body, metal grains in the eyes, history of back pain that makes prolonged laying on the PET or MRI scanner intolerable)

Exclusion Criteria

Known carriers for mutations in the following genes: alpha-synuclein, LRRK2, GBA, PRKN, PINK1, or DJ1
_
Disease of the central nervous system (other than Parkinson's disease), for example Stroke, Dementia, Epilepsy
Previous brain surgery for Parkinson's disease (including deep brain stimulation [DBS])
Presence of any psychiatric condition, for example schizophrenia
History of cancer, except for appropriately treated, non-melanoma skin carcinoma, non-metastatic prostate cancer, treated carcinoma in situ of the cervix or Stage I uterine cancer
Major vascular surgery within the last 6 months
Autoimmune diseases
Chronic liver diseases
Uncontrolled hypertension
Immunodeficiency diseases, e.g. HIV
Hepatitis B or C
Vaccine(s) other than SARS-CoV2 vaccine within 28 days prior to the first dose, or plans to receive vaccines during the study or within 28 days of the last dose
Enrollment in another investigational study
Drug and/or alcohol abuse within the last 12 months
Resident of a nursing home or assisted care facility
Donation or loss of blood over 500 mL within 90 days prior to baseline. Plasma donation of 150 mL or more within 7 days prior to baseline
Any contradictions to obtaining a brain MRI or TSPO-PET (e.g., claustrophobia, metal devices or implants, metal deposited in the body, metal grains in the eyes, history of back pain that makes prolonged laying on the PET or MRI scanner intolerable)
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