What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease with potential neuroprotective or disease-modifying effects include cholinesterase inhibitors, MAO B inhibitors, and dopaminergic therapies. Cholinesterase inhibitors, such as rivastigmine and donepezil, can cause side effects like nausea, vomiting, and worsened tremor. MAO B inhibitors, which are used to augment the effects of levodopa, may lead to side effects such as headache, dizziness, and insomnia. Dopaminergic therapies, including levodopa and dopamine agonists, can result in nausea, somnolence, dizziness, and more serious effects like hallucinations, delusions, and orthostatic hypotension. These side effects highlight the importance of careful monitoring and individualized treatment plans.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of Parkinson's Disease, focusing on symptomatic relief and potential disease-modifying effects. Levodopa, often combined with carbidopa, remains the cornerstone for symptomatic treatment. Dopamine agonists like pramipexole, ropinirole, and transdermal rotigotine are also widely used. MAO-B inhibitors such as selegiline and rasagiline offer modest symptomatic benefits and are sometimes considered for their potential neuroprotective effects. Additionally, VMAT2 inhibitors like tetrabenazine and deutetrabenazine are used for managing chorea associated with Huntington's Disease but have implications for PD treatment. While these treatments primarily address symptoms, ongoing research, including the BIIB122 trial, aims to explore drugs with potential disease-modifying properties.

What other types of research exist?

Several promising alternatives to BIIB122 for Parkinson's Disease treatment include: 1) Piperine analogues, which activate the Nrf2/keap1 pathway and have shown neuroprotective effects in preclinical models. 2) DJ-1 stimulatory modulators like UCP0054278, which offer dopaminergic neuroprotection. 3) Rebamipide, which mitigates mitochondrial dysfunction and oxidative stress. 4) Nicotine analogs identified through machine learning, which have potential neuroprotective activity via the PI3K/AKT pathway. 5) Static magnetic field (SMF) exposure, which mimics the effects of the PD drug candidate ZM241385 and offers a non-invasive treatment approach.

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Monoclonal Antibodies

BIIB122 for Early-Stage Parkinson's Disease (LUMA Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for Parkinson's Disease (PD) primarily aim to manage symptoms and potentially offer neuroprotective benefits. Dopaminergic therapies, such as levodopa and dopamine agonists, work by replenishing or mimicking dopamine, a neurotransmitter deficient in PD patients, thereby improving motor function. MAO B inhibitors, like rasagiline and selegiline, prevent the breakdown of dopamine, enhancing its availability in the brain. Neuroprotective agents, including those under investigation like BIIB122, target underlying disease mechanisms, such as oxidative stress, mitochondrial dysfunction, and protein aggregation, to slow disease progression. These treatments are crucial for PD patients as they not only alleviate symptoms but also hold the potential to modify the disease course, improving long-term outcomes.

Phase 2

Recruiting

Research Sponsored by Biogen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Modified Hoehn and Yahr scale stages 1 to 2 (in OFF state), inclusive, at screening

Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria within 2 years of the Screening Visit, inclusive, and at least 30 years of age at the time of diagnosis

Must not have

Clinical evidence of atypical parkinsonism (e.g., multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism

Montreal Cognitive Assessment (MoCA) score <24 at the screening visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to a minimum of 48 weeks and a maximum of 144 weeks

Summary

This trial is testing a new drug called BIIB122 to see if it can slow down symptoms in people with early-stage Parkinson's disease. The drug works by blocking a protein that may cause the disease to get worse. Participants will take the drug for several years to see if it helps.

Who is the study for?

This trial is for people aged 30-80 with early-stage Parkinson's disease, diagnosed within the last two years. Participants should have mild symptoms (stages 1 to 2 on a specific scale) and score ≤40 on a PD symptom questionnaire. They can't join if they have other significant neurological issues, atypical parkinsonism, drug-induced parkinsonism, or cognitive impairment as indicated by a MoCA score <24.

What is being tested?

The study tests BIIB122 tablets against placebo to see if it slows down symptom worsening in early Parkinson's over a period of up to three years. Patients will take either the drug or placebo daily and attend clinic visits every three months. The effectiveness will be measured using the MDS-UPDRS questionnaire assessing PD symptoms' impact on daily life.

What are the potential side effects?

While specific side effects of BIIB122 are not listed here, clinical trials typically monitor for any adverse reactions ranging from mild (like headaches or nausea) to severe (such as allergic reactions). Safety information will be gathered throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My Parkinson's is in the early to mid stages.

Select...

I was diagnosed with Parkinson's disease within the last 2 years and was over 30 at diagnosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a rare form of Parkinson's or my Parkinson's may be caused by medication.

Select...

My memory and thinking test score was below 24.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to a minimum of 48 weeks and a maximum of 144 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to a minimum of 48 weeks and a maximum of 144 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to a minimum of 48 weeks and a maximum of 144 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score Over the Treatment Period

Secondary study objectives

Change From Baseline in MDS-UPDRS Parts I, II, and III Combined Score

Change From Baseline in MDS-UPDRS Parts II and III Combined Score

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BIIB122 225 mgExperimental Treatment1 Intervention

Participants will receive BIIB122, 225 mg tablets, by mouth, once daily (QD) for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received BIIB122 and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122, 225 mg tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks.

Group II: BIIB122 Matching PlaceboPlacebo Group1 Intervention

Participants will receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received placebo and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BIIB122

2024

Completed Phase 1

~110

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Parkinson's Disease (PD) primarily aim to manage symptoms and potentially offer neuroprotective benefits. Dopaminergic therapies, such as levodopa and dopamine agonists, work by replenishing or mimicking dopamine, a neurotransmitter deficient in PD patients, thereby improving motor function. MAO B inhibitors, like rasagiline and selegiline, prevent the breakdown of dopamine, enhancing its availability in the brain. Neuroprotective agents, including those under investigation like BIIB122, target underlying disease mechanisms, such as oxidative stress, mitochondrial dysfunction, and protein aggregation, to slow disease progression. These treatments are crucial for PD patients as they not only alleviate symptoms but also hold the potential to modify the disease course, improving long-term outcomes.

Advances in drug development for Parkinson's disease: present status.Neuropharmacological approach against MPTP (1-methyl-4-phenyl-1,2,3,6- tetrahydropyridine)-induced mouse model of Parkinson's disease.