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New pill aims to smooth Parkinson's movement swings

NCT ID NCT05766813

Disease control Sponsor: Intra-Cellular Therapies, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study tested a drug called lenrispodun in 79 people with Parkinson's disease who experience 'wearing off' symptoms and involuntary movements. Participants took the drug or a placebo once daily alongside their usual treatment. The goal was to see if lenrispodun could improve motor control and reduce troublesome symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lenrispodun (a drug taken as a tablet once daily)
What this could lead to
If it works, lenrispodun could help people with Parkinson's have more 'on' time with fewer movement problems, improving daily life.
What could go wrong
This is an early Phase 2 trial with only 79 people, so results may not apply widely. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

79 people

The number who actually took part.

Started

Mar 2023

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female between 40 years of age and older 2. Body mass index of 19.0-40.0 kg/m2; 3. Diagnosis of PD that is consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria; 4. Hoehn and Yahr Scale stage classification of 2 or 3 when in the ON state; 5. Have a clinically meaningful response to levodopa (levodopa + DDCI combination) based on Investigator assessment, and meet the following: 1. Have been on a stable and optimal dose of levodopa (levodopa + DDCI combination: minimum dose of levodopa equivalent to 100 mg three times daily) for at least 4 weeks prior to Screening, and are expected to continue the same dose regimen throughout the Double-blind Treatment Period; 2. If taking other anti-parkinsonian medications (MAO-B \[monoamine oxidase B\] inhibitor, COMT \[catechol-O-methyltransferase\] inhibitor, dopamine agonist) in addition to levodopa, have been on a stable dose for at least 4 weeks prior to Screening and are expected to continue the same dose regimen throughout the Double-blind Treatment Period; 7\. Have wearing-off symptoms and levodopa-induced dyskinesia as per Investigator judgment; 8. Properly complete and return a self-reported home diary for motor function status (Hauser Diary) during the Screening Period, which confirms 3 days (ie, 3 consecutive, 24-hour periods) immediately prior to Baseline, each with at least 2½ hours of OFF time during waking hours. 9\. Has a caregiver to assist with study participation, if determined by the Investigator to be necessary. Exclusion Criteria: 1. Medical history indicating parkinsonism other than idiopathic PD, including but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia; 2. 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; 3. Exhibits clinical signs of dementia as indicated by the Mini-Mental State Examination, 2nd Edition: Standard Version (MMSE-2:SV) score of ≤ 24; 4. Use of moderate or strong CYP3A4 inhibitors within 5 half-lives of Baseline or CYP3A4 inducers within 2 weeks of Baseline; 5. Daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of acetylsalicylic acid (ASA); 6. Use of MAO-A inhibitors, phosphodiesterase type 5 (PDE5) inhibitors, or alpha blockers including tamsulosin, within 5 half-lives of Baseline;

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

Contacts and locations

Locations

  • Clinical Site

    Phoenix, Arizona, 85013, United States

  • Clinical Site

    Scottsdale, Arizona, 85251, United States

  • Clinical Site

    Irvine, California, 92697, United States

  • Clinical Site

    Loma Linda, California, 92354, United States

  • Clinical Site

    Altamonte Springs, Florida, 32714, United States

  • Clinical Site

    Boca Raton, Florida, 33486, United States

  • Clinical Site

    Coral Springs, Florida, 33067, United States

  • Clinical Site

    Doral, Florida, 33178, United States

  • Clinical Site

    Hallandale, Florida, 33009, United States

  • Clinical Site

    Maitland, Florida, 32751, United States

  • Clinical Site

    Miami, Florida, 33136, United States

  • Clinical Site

    Ocala, Florida, 34470, United States

  • Clinical Site

    Orlando, Florida, 32804, United States

  • Clinical Site

    Orlando, Florida, 32825, United States

  • Clinical Site

    Port Orange, Florida, 32127, United States

  • Clinical Site

    Tampa, Florida, 33612, United States

  • Clinical Site

    Augusta, Georgia, 30912, United States

  • Clinical Site

    Decatur, Georgia, 30030, United States

  • Clinical Site

    Kansas City, Kansas, 66160, United States

  • Clinical Site

    Farmington Hills, Michigan, 48334, United States

  • Clinical Site

    Golden Valley, Minnesota, 55427, United States

  • Clinical Site

    Albany, New York, 12208, United States

  • Clinical Site

    Rock Hill, South Carolina, 29732, United States

  • Clinical Site

    Franklin, Tennessee, 37067, United States

  • Clinical Site

    Memphis, Tennessee, 38157, United States

  • Clinical Site

    Austin, Texas, 78746, United States

  • Clinical Site

    Dallas, Texas, 75243, United States

  • Clinical Site

    Georgetown, Texas, 78628, United States

  • Clinical Site

    Alexandria, Virginia, 22311, United States

  • Clinical Site

    Falls Church, Virginia, 22042, United States

  • Clinical Site

    Henrico, Virginia, 23233, United States

  • Clinical Site

    Kirkland, Washington, 98034, United States

  • Clinical Site

    Spokane, Washington, 99202, United States

  • Clinical Site

    Crab Orchard, West Virginia, 25827, United States

  • Clinical Site

    Milwaukee, Wisconsin, 53226, United States

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