Lenrispodun for Parkinson's Disease

Recruiting at32 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Lenrispodun (Other)
• Placebo (Adjunctive Therapy)

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.

Participant Groups

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+