What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as levodopa and dopamine agonists, have well-documented side effects. Levodopa can cause nausea, somnolence, dizziness, headache, confusion, hallucinations, delusions, agitation, psychosis, and orthostatic hypotension. Dopamine agonists, including pramipexole, ropinirole, and rotigotine, are associated with non-motor side effects like edema, somnolence, constipation, dizziness, hallucinations, and nausea. Cholinesterase inhibitors, used for cognitive impairment in Parkinson's Disease, can worsen tremor and cause nausea. Investigational drugs like Lu AF28996 are still being studied for safety and tolerability, but they may share similar side effects with existing dopaminergic therapies.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, particularly focusing on dopaminergic therapies. Key approved drugs include levodopa, often combined with carbidopa, which remains the gold standard for PD treatment. Nonergot dopamine agonists such as pramipexole, ropinirole, and the transdermal patch rotigotine have also been approved and are widely used. These medications help to manage motor symptoms by stimulating dopamine receptors. Additionally, MAO-B inhibitors like selegiline and rasagiline are used to inhibit the breakdown of dopamine, thereby extending its action. These treatments are similar in their dopaminergic approach to the investigational drug Lu AF28996.

What other types of research exist?

Promising alternatives to Lu AF28996 for Parkinson's Disease patients include: 1) Rasagiline, which is a valuable therapeutic alternative to entacapone and can be used alongside levodopa. 2) Amantadine, known for its antidyskinetic effects when used as an adjunct to L-DOPA. 3) Second-generation, non-ergolinic dopamine receptor agonists, which can be used as monotherapy in early PD or combined with L-DOPA in advanced stages. These alternatives offer different mechanisms of action and can be tailored to individual patient needs.

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Lu AF28996 for Parkinson's Disease

Phase 1

Recruiting

Research Sponsored by H. Lundbeck A/S

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 5.5 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called Lu AF28996 to see if it is safe and well-tolerated in people with Parkinson's disease. The study will check how the body processes the drug and if it causes any side effects. Participants will take the drug at different frequencies during the study.

Who is the study for?

This trial is for men and women with Parkinson's Disease who respond well to levodopa, have been on a stable dose for at least 4 weeks, and experience significant motor fluctuations. They should not have other major neurological issues or serious health conditions like liver problems, respiratory diseases, or immune disorders.

What is being tested?

The study is testing the safety and tolerability of a drug called Lu AF28996 in people with Parkinson's. It also looks at how the body processes this drug. Participants will be monitored to see how they react to Lu AF28996 over time.

What are the potential side effects?

While specific side effects of Lu AF28996 are not listed here, common side effects in trials like this may include nausea, dizziness, sleep disturbances, headache or worsening of PD symptoms. Each person might experience different side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 5.5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 5.5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 5.5 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cmax of Lu AF28996

Number of Participants with Treatment-emergent Adverse Events

Tmax of Lu AF28996

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lu AF28996Experimental Treatment1 Intervention

Participants in Part A will receive ascending oral doses of Lu AF28996 OD for 14 days in all OD cohorts, followed by down-titration as per Investigator's judgement. For the BID Cohort A1, participants will receive Lu AF28996 BID for 24 days, followed by down-titration as per Investigator's judgement. For the BID Cohort A2, participants will receive Lu AF28996 BID for 39 days, followed by down-titration as per Investigator's judgement. Participants in Part B (Cohorts B1, B2, and B3) will receive Lu AF28996 BID for 41 days, followed by down-titration as per Investigator's judgement

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lu AF28996

2024

Completed Phase 1

~40

Do I qualify?Apply below to find out

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

The most common treatments for Parkinson's Disease (PD) primarily aim to increase dopamine levels or mimic its action in the brain, as dopamine deficiency is a hallmark of PD. Levodopa, often combined with carbidopa, is converted to dopamine in the brain, directly replenishing dopamine levels. Dopamine agonists (e.g., pramipexole, ropinirole) bind to dopamine receptors, mimicking dopamine's effects. MAO-B inhibitors (e.g., rasagiline, selegiline) prevent the breakdown of dopamine, prolonging its action. Amantadine promotes dopamine release and has anticholinergic effects. These treatments are crucial as they help manage motor symptoms, improving the quality of life for PD patients. Investigational drugs like Lu AF28996 are being studied to offer potentially new mechanisms or improved efficacy in managing PD symptoms.