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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 belowSelect...
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:Select...
I have late-stage Parkinson's with severe and unpredictable symptom changes.
Select...
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
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.
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.
Amantadine reduces levodopa-induced dyskinesias in parkinsonian monkeys.Amantadine as treatment for dyskinesias and motor fluctuations in Parkinson's disease.
Find a Location
Who is running the clinical trial?
Intra-Cellular Therapies, Inc.Lead Sponsor
36 Previous Clinical Trials
9,272 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I take NSAIDs or aspirin daily.I haven't taken MAO-A inhibitors, PDE5 inhibitors, or alpha blockers like tamsulosin recently.I am between 40 and 80 years old.Your body mass index (BMI) is between 19.0 and 40.0.You have been diagnosed with Parkinson's disease using specific diagnostic criteria from the UK Parkinson's Disease Society.My Parkinson's is moderate, and I can move with little to some help.My condition improves with levodopa treatment.I have been on a stable dose of levodopa for Parkinson's for at least 4 weeks.I've been on a stable dose of my Parkinson's medication for at least 4 weeks.I have completed a diary for 3 days showing I have at least 2.5 hours of OFF time daily.My Parkinson's disease is not caused by other conditions or drugs.I have late-stage Parkinson's with severe and unpredictable symptom changes.You show signs of memory and thinking problems based on a test score of 24 or lower.I haven't taken strong medication that affects liver enzymes recently.You have symptoms that come back before your next dose of medication and you have uncontrolled movements caused by your medication, according to the doctor's opinion.
Research Study Groups:
This trial has the following groups:- Group 1: Lenrispodun 30 mg
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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