Lenrispodun for Parkinson's Disease

Recruiting at 33 trial locations

Overseen By ITI Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Intra-Cellular Therapies, Inc.

Must be taking: Levodopa, MAO-B inhibitors

Must not be taking: CYP3A4 inhibitors, NSAIDs

Disqualifiers: Late-stage PD, Dementia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Lenrispodun, a new treatment for people with Parkinson's disease who experience "wearing off" symptoms and involuntary movements caused by levodopa. The study aims to determine if Lenrispodun can reduce these symptoms compared to a placebo (a pill with no active medication). People diagnosed with Parkinson's disease, who have been on a stable dose of levodopa and experience these specific symptoms, might be a good fit for this trial. As a Phase 2 trial, this research measures how well Lenrispodun works in an initial, smaller group of people, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of your current Parkinson's medications, like levodopa and other anti-parkinsonian drugs, throughout the study. However, you must stop using certain other medications, like moderate or strong CYP3A4 inhibitors, MAO-A inhibitors, and some others, before the trial begins.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lenrispodun is generally safe for people with Parkinson's disease. Clinical data indicate that lenrispodun, also known as ITI-214, is usually well tolerated by patients with mild to moderate Parkinson's. In past studies, patients experienced few serious side effects at different doses, suggesting the treatment is likely well-tolerated. Although the current trial is in an early stage, the safety record from previous research appears promising for those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's Disease?

Lenrispodun is unique because it offers a new approach to treating Parkinson’s disease. Unlike standard treatments like levodopa, which primarily aim to replenish dopamine levels, Lenrispodun works differently by targeting specific pathways in the brain that are involved in the disease. This new mechanism of action could potentially improve symptoms more effectively or with fewer side effects. Researchers are excited about Lenrispodun because it represents a fresh strategy that might enhance the quality of life for people living with Parkinson’s.

What evidence suggests that Lenrispodun might be an effective treatment for Parkinson's Disease?

Research suggests that lenrispodun, which participants in this trial may receive, could help alleviate Parkinson's disease symptoms. Studies have shown that lenrispodun blocks a specific enzyme, potentially reducing movement problems and improving mobility in patients. Previous trials found it safe and generally well tolerated in people with mild to moderate Parkinson's disease. Additionally, lenrispodun might reduce inflammation, which can aid in managing the disease. Overall, early evidence supports lenrispodun as a potentially effective treatment for Parkinson's disease symptoms. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

I take NSAIDs or aspirin daily.

I haven't taken MAO-A inhibitors, PDE5 inhibitors, or alpha blockers like tamsulosin recently.

My Parkinson's disease is not caused by other conditions or drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Double-blind Treatment

Participants are randomized to receive either placebo or Lenrispodun 30 mg/day

4 weeks

Safety Follow-up

Participants return to the clinic for a safety follow-up visit approximately one week after the last dose of study treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Lenrispodun
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Lenrispodun 30 mg Experimental Treatment 1 Intervention

Lenrispodun 30 mg tablets administered orally, once-daily.

Group II: Placebo Placebo Group 1 Intervention

Matching tablets administered orally, once daily.

Who Is Running the Clinical Trial?

Intra-Cellular Therapies, Inc.

Lead Sponsor

Trials

42

Recruited

10,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05766813

Study Details | NCT05766813 | Lenrispodun as Adjunctive ... Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease · Study Overview · Contacts and Locations.

2. neurology.org neurology.org/doi/10.1212/WNL.92.15_supplement.P2.8-051

ITI-214, A Novel Phosphodiesterase I Inhibitor for the ... Clinical data indicate that ITI-214 is safe and generally well tolerated across a range of doses in patients with mild to moderate PD. Signals ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03257046

Study Details | NCT03257046 | Safety, Tolerability, ... This is a Phase I/II randomized, double-blind, placebo-controlled, multiple rising dose study in patients with stable idiopathic Parkinson's disease (PD) to ...

4. biospace.com biospace.com/intra-cellular-therapies-announces-publications-highlighting-beneficial-effects-of-phosphodiesterase-type-i-inhibition-with-lenrispodun-iti-214-on-cardiovascular-function-in-patients-with-heart-failure-and-in-models-of-accelerated-aging

Results of Study ITI-214-104 show that lenrispodun, in a ... Lenrispodun is in clinical development for the treatment of symptoms associated with Parkinson's disease and for the treatment of heart failure.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7783477/

Inhibition of calcium-calmodulin-dependent ... - PubMed Central These studies are the first to demonstrate that inhibition of PDE1 exerts anti-inflammatory effects through effects on microglia signaling pathways.

6. evergreenhealth.com evergreenhealth.com/health-services/clinical-trials/find-a-clinical-trial/details/?id=54

Lenrispodun as Adjunctive Therapy in the Treatment of ... This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a diagnosis of Parkinson's Disease.

7. aan.com aan.com/MSA/Public/Events/AbstractDetails/41610

Abstract Details Evaluate the safety and tolerability of ITI-214, a potent and selective phosphodiesterase 1 (PDE1) inhibitor, in patients with Parkinson's disease (PD).