What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as Levodopa, Dopamine Agonists, and Amantadine, have various side effects. Levodopa can cause nausea, somnolence, dizziness, headache, confusion, hallucinations, delusions, agitation, psychosis, and orthostatic hypotension. Dopamine Agonists may lead to edema, somnolence, constipation, dizziness, hallucinations, and nausea. Amantadine, an NMDA receptor antagonist, can cause confusion, orthostatic hypotension, insomnia, and visual hallucinations. These side effects are generally managed by adjusting doses and monitoring the patient's response.

What prior FDA approvals exist?

Amantadine, an NMDA receptor antagonist, has been approved by the FDA for the treatment of Parkinson's Disease, particularly for managing motor symptoms such as tremor, bradykinesia, and rigidity. Other FDA-approved treatments for Parkinson's Disease include levodopa, often combined with carbidopa, which remains the most effective treatment for motor symptoms. Dopamine agonists like pramipexole and ropinirole, MAO-B inhibitors such as selegiline and rasagiline, and anticholinergics like trihexyphenidyl are also approved and used based on patient-specific needs and symptom profiles.

What other types of research exist?

Promising novel alternatives to Amantadine for Parkinson's Disease patients include: 1) Safinamide, which has shown efficacy in improving motor symptoms and reducing dyskinesias; 2) Rotigotine transdermal system, which helps manage motor function and sleep disturbances; 3) Deep brain stimulation (DBS), which has been effective in improving motor symptoms and quality of sleep. These alternatives offer different mechanisms of action and may provide additional benefits for PD patients.

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Lenrispodun for Parkinson's Disease

Verified Trial

Phase 2

Recruiting

Research Sponsored by Intra-Cellular Therapies, Inc.

Eligibility Criteria Checklist

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

Must have

Male or female between 40 and 80 years of age, inclusive

Hoehn and Yahr Scale stage classification of 2 or 3 when in the ON state

Must not have

Has late-stage PD, severe peak-dose dyskinesia, clinically significant end-dose or biphasic dyskinesia, and/or unpredictable or widely swinging fluctuations in their symptoms as assessed by the Investigator

Daily use of nonsteroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid (ASA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 29

Summary

This trial is testing a medication called Lenrispodun to help people with Parkinson's Disease. It aims to reduce symptoms that appear when their usual medication stops working and to control involuntary movements caused by their current treatment. The study involves an initial check-up, a phase where patients receive either Lenrispodun or another substance, and a later check-up to ensure safety.

Who is the study for?

This trial is for adults aged 40-80 with Parkinson's Disease, experiencing motor fluctuations and levodopa-induced dyskinesia. They must respond well to levodopa treatment, have a stable medication regimen, and be able to track their motor function. Excluded are those with other forms of parkinsonism, severe PD symptoms or dementia, and users of certain drugs like MAO-A inhibitors.

What is being tested?

The study tests Lenrispodun against a placebo in managing Parkinson's symptoms. Participants will be randomly assigned to receive either the drug or placebo alongside their regular medications in a controlled environment across multiple centers.

What are the potential side effects?

While specific side effects for Lenrispodun aren't listed here, similar trials may include risks such as nausea, dizziness, sleep disturbances or worsening of some Parkinson's symptoms.

Eligibility Criteria

Inclusion Criteria

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

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I am between 40 and 80 years old.

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My Parkinson's is moderate, and I can move with little to some help.

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I have been on a stable dose of levodopa for Parkinson's for at least 4 weeks.

Exclusion Criteria

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

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I have late-stage Parkinson's with severe and unpredictable symptom changes.

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I take NSAIDs or aspirin daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hauser Diary

Secondary study objectives

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lenrispodun 30 mgExperimental Treatment1 Intervention

Lenrispodun 30 mg tablets administered orally, once-daily.

Group II: PlaceboPlacebo Group1 Intervention

Matching tablets administered orally, once daily.

0 / 5Eligibility 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

Parkinson's Disease treatments primarily aim to manage symptoms by addressing dopamine deficiency and motor complications. Levodopa, often combined with carbidopa, is the most effective treatment, converting to dopamine in the brain to improve motor function. Dopamine agonists (e.g., pramipexole, ropinirole) mimic dopamine effects, while MAO-B inhibitors (e.g., rasagiline) prevent dopamine breakdown. Amantadine, an NMDA receptor antagonist, helps reduce dyskinesias by modulating glutamate activity, which is crucial for patients experiencing levodopa-induced motor complications. These treatments are essential as they improve quality of life by alleviating motor symptoms and managing side effects.

Amantadine reduces levodopa-induced dyskinesias in parkinsonian monkeys.Amantadine as treatment for dyskinesias and motor fluctuations in Parkinson's disease.