What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as levodopa, dopamine agonists, and cholinesterase inhibitors, have a range of side effects. Levodopa can cause nausea, somnolence, dizziness, headache, confusion, hallucinations, and orthostatic hypotension. Dopamine agonists may lead to edema, somnolence, constipation, dizziness, hallucinations, and nausea. Cholinesterase inhibitors, used for cognitive impairment in PD, can worsen tremor and cause nausea and vomiting. For treatments similar to BIIB094, which targets LRRK2, specific side effects are not detailed, but monitoring for typical adverse reactions seen with other PD medications is advisable.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, primarily focusing on symptom management. These include levodopa, often combined with carbidopa, and dopamine agonists like pramipexole and ropinirole. Additionally, MAO-B inhibitors such as selegiline and rasagiline are used to prolong the effects of dopamine. While there are no specific mentions of FDA-approved LRRK2 inhibitors or modulators similar to BIIB094 in the provided context, ongoing research and trials, such as the one for BIIB094, indicate a growing interest in targeting genetic factors like LRRK2 mutations in Parkinson's Disease.

What other types of research exist?

Promising alternatives to BIIB094 for Parkinson's Disease patients include: 1) ONO-2160, a levodopa pro-drug combined with carbidopa, which aims to stabilize levodopa plasma concentration fluctuations. 2) Pramipexole and ropinirole, dopamine agonists that have shown potential in slowing the decline of striatal dopaminergic signals. 3) Zonisamide, which has demonstrated improvement in motor function as an adjunctive treatment to levodopa. These alternatives have shown efficacy and safety in recent clinical trials and may be considered for treatment in 2024.

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Monoclonal Antibodies

BIIB094 for Parkinson's Disease (REASON Trial)

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

Common treatments for Parkinson's Disease (PD) primarily aim to manage motor symptoms by addressing dopamine deficiency in the brain. Levodopa, often combined with carbidopa, is the most effective treatment, converting to dopamine in the brain to replenish low levels. Dopamine agonists (e.g., pramipexole, ropinirole) mimic dopamine's effects, while MAO-B inhibitors (e.g., selegiline, rasagiline) prevent dopamine breakdown. COMT inhibitors (e.g., entacapone) extend the effect of levodopa by inhibiting its metabolism. Treatments like BIIB094, a potential LRRK2 inhibitor, target genetic mutations linked to PD, aiming to modify disease progression by reducing abnormal protein activity. These mechanisms are crucial as they not only alleviate symptoms but also hold potential for slowing disease progression, improving quality of life for PD patients.

Phase 1

Waitlist Available

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 Stage ≤ 3

Modified Hoehn and Yahr Stage ≤ 3.

Must not have

History of any brain surgery for PD or a history of focused ultrasound treatment at any time; or history of neuromodulation procedures

Poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within 3 months before dosing (Day 1) or glycosylated hemoglobin value greater than or equal to (≥) 8 percent (%) at Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part a: screening (day -42) up to day 85, part b: screening (day -77) up to day 253

Summary

This trial tests the safety and behavior of a drug called BIIB094 in patients with Parkinson's Disease, including those with different genetic backgrounds.

Who is the study for?

This trial is for adults with Parkinson's Disease diagnosed within the last 7 years, without severe motor issues or dyskinesia. Participants must understand study risks, give informed consent, and have a Modified Hoehn and Yahr Stage ≤ 3. Excluded are those with recent heart problems, uncontrolled diabetes, certain infections like hepatitis C or HIV, recent strokes or loss of consciousness, cognitive impairments (MoCA score <23), or brain surgery history for PD.

What is being tested?

The trial tests BIIB094 administered via spinal injection to see if it's safe and tolerable in single/multiple doses compared to a placebo. It also looks at how the body processes this drug. The study includes people with variations in the LRRK2 gene related to PD as well as those without genetic variants.

What are the potential side effects?

While specific side effects aren't listed here, common ones from intrathecal injections may include headache, back pain, nausea and potential risk of infection at the injection site. Side effects from BIIB094 will be closely monitored given its experimental nature.

Eligibility Criteria

Inclusion Criteria

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

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My Parkinson's disease is at an early or mid-stage.

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My Parkinson's disease is at an early or mid-stage.

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It seems like the criterion is incomplete. Could you please provide more information or context so that I can assist you accurately?

Exclusion Criteria

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

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I have never had brain surgery or focused ultrasound for Parkinson's disease, nor any neuromodulation procedures.

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My diabetes is not well-controlled, with recent medication changes or HbA1c ≥ 8%.

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I have not had a stroke, mini-stroke, or unexplained fainting in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part a: screening (day -42) up to day 85, part b: screening (day -77) up to day 253

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part a: screening (day -42) up to day 85, part b: screening (day -77) up to day 253

This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: screening (day -42) up to day 85, part b: screening (day -77) up to day 253 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Trial Design

13Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B (MAD): BIIB094 Dose 1Experimental Treatment1 Intervention

Participants will receive a single IT injection of BIIB094 on multiple days during Part B \[Multiple Ascending Dose (MAD)\].

Group II: Part B (MAD): BIIB094 (Non LRRK2) Dose 3Experimental Treatment1 Intervention

Participants (Non LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).

Group III: Part B (MAD): BIIB094 (Non LRRK2) Dose 2Experimental Treatment1 Intervention

Participants \[Non leucine-rich repeat kinase 2 (Non LRRK2)\] will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).

Group IV: Part B (MAD): BIIB094 (LRRK2) Dose 3Experimental Treatment1 Intervention

Participants (LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).

Group V: Part B (MAD): BIIB094 (LRRK2) Dose 2Experimental Treatment1 Intervention

Participants (LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).

Group VI: Part A (SAD): BIIB094 Dose 6Experimental Treatment1 Intervention