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New pill aims to cut Parkinson's 'OFF' episodes

NCT ID NCT06055985

Symptom relief Sponsor: UCB Biopharma SRL 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This Phase 2 trial tested an experimental drug called UCB0022 in 207 people with advanced Parkinson's disease. The goal was to see if adding UCB0022 to standard treatment could reduce the daily hours spent in the 'OFF' state, when Parkinson's symptoms return. Participants took either UCB0022 or a placebo tablet for 70 days and recorded their symptoms in a diary.

What this could mean

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

Active substance
UCB0022 (a drug taken as a tablet)
What this could lead to
If successful, UCB0022 could become a new add-on treatment to help people with advanced Parkinson's spend less time in the 'OFF' state, when symptoms return between medication doses.
What could go wrong
This is a Phase 2 trial, so it is still early. The drug may not work better than placebo, and side effects are possible. Results may not apply to all Parkinson's patients.

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

207 people

The number who actually took part.

Started

Nov 2023

Finished

Apr 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

35 to 85 years

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: * Study participant must be 35 to 85 years of age (inclusive) at the time of signing the informed consent form (ICF) * Study participant is diagnosed with Parkinson's disease (PD) (based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic criteria performed at the Screening Visit) and diagnosed ≥5 years before the Screening Visit (based on historical medical- information documented by the investigator) * Study participant has significant daily motor fluctuations * Study participant is able to complete a Hauser PD symptoms diary and differentiate between the ON and OFF states * Study participant is responsive to levodopa and currently receiving treatment with oral daily doses of levodopa combination (levodopa/carbidopa or levodopa/benserazide) with or without oral adjunctive antiparkinsonian therapies (based on historical clinical data) * Study participant has disease severity Stages I-III (modified Hoehn and Yahr staging) during ON state * Study participant agrees to not post personal medical data or information related to the study on social media until study completion * Study participant has body weight ≥45 kg and body mass index within 18 to 30 kg/m\^2 (inclusive) * Study participant may be male or female: 1. A male study participant must agree to use contraception during the Treatment Period and for at least 2 weeks after the last dose of study treatment and refrain from donating sperm during this period 2. A female study participant must not be a woman of childbearing potential (WOCBP) Exclusion Criteria: * Study participant is diagnosed with any form of Parkinsonism other than idiopathic PD (eg, atypical or secondary Parkinsonism) * Study participant is diagnosed with dementia or has important cognitive dysfunction, as determined by Montreal Cognitive Assessment (MoCA) \<23 at screening * Study participant has a history of neurosurgical intervention for PD (including DBS, thalamotomy, and experimental cell therapy or gene therapy) * Participant has a severe peak dose or biphasic dyskinesia at screening, defined by Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) items 4.2 score 4 or as per investigator opinion * Participant has a history of major depression or psychotic disorder or any other psychiatric condition within the past 5 years, that, as per investigator opinion, could jeopardize or would compromise the study participant's ability to participate in the study * Study participant has a history of narrow angle glaucoma * Study participant has a history of melanoma * Study participant has current untreated hypertension * Study participant has a history of hypertensive crisis and/or hypertensive encephalopathy, unless the underlying cause was unequivocally identified and has been removed * Study participant has orthostatic hypotension requiring medication or a current history of "clinically significant" orthostatic hypotension as per the investigator's opinion (eg, recurrent orthostatic presyncope or syncope) * Study participant has a history over the past 12 months or between the Screening and Baseline Visits of any clinically significant arrythmia, myocardial infarction, stroke, transient ischemic attack, moderate or severe congestive heart failure (either New York Heart Association Class III or IV or known ejection fraction \<40%)

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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

  • Pd0060 50074

    Kansas City, Kansas, 66160, United States

  • Pd0060 50075

    Augusta, Georgia, 30912, United States

  • Pd0060 50076

    Columbus, Ohio, 43221, United States

  • Pd0060 50085

    Boston, Massachusetts, 02215, United States

  • Pd0060 50087

    Centerville, Ohio, 45459, United States

  • Pd0060 50110

    Ann Arbor, Michigan, 48109-0944, United States

  • Pd0060 50143

    Henrico, Virginia, 23233, United States

  • Pd0060 50292

    Kirkland, Washington, 98034, United States

  • Pd0060 50319

    Iowa City, Iowa, 52242, United States

  • Pd0060 50386

    Farmington Hills, Michigan, 48334, United States

  • Pd0060 50398

    Tulsa, Oklahoma, 74136, United States

  • Pd0060 50402

    Crab Orchard, West Virginia, 25827, United States

  • Pd0060 50419

    Spokane, Washington, 99202, United States

  • Pd0060 50428

    Fresno, California, 93710, United States

  • Pd0060 50440

    Bellevue, Washington, 98004, United States

  • Pd0060 50449

    Miami, Florida, 33133, United States

  • Pd0060 50452

    Pasadena, California, 91106, United States

  • Pd0060 50496

    Round Rock, Texas, 78681, United States

  • Pd0060 50506

    Phoenix, Arizona, 85004, United States

  • Pd0060 50519

    Fountain Valley, California, 92708, United States

  • Pd0060 50521

    New York, New York, 10029, United States

  • Pd0060 50524

    Bradenton, Florida, 34205, United States

  • Pd0060 50527

    Toledo, Ohio, 43614, United States

  • Pd0060 50534

    Virginia Beach, Virginia, 23456, United States

  • Pd0060 50537

    Salt Lake City, Utah, 84108, United States

  • Pd0060 50545

    East Lansing, Michigan, 48824, United States

  • Pd0060 50561

    Lexington, Kentucky, 40536-0284, United States

  • Pd0060 50568

    San Antonio, Texas, 78229, United States

  • Pd0060 50577

    Doral, Florida, 33172, United States

  • Pd0060 50579

    Miami, Florida, 33125, United States

  • Pd0060 50580

    Miami, Florida, 33176, United States

  • Pd0060 50582

    Miami, Florida, 33122, United States

  • Pd0060 50584

    Hollywood, Florida, 33021, United States

  • Pd0060 50585

    Winter Park, Florida, 32789, United States

  • Pd0060 50587

    Los Angeles, California, 90033, United States

  • Pd0060 50589

    Los Alamitos, California, 90720, United States

  • Pd0060 50590

    Scottsdale, Arizona, 85258, United States

  • Pd0060 50591

    Ocala, Florida, 34470, United States

  • Pd0060 50595

    Indianapolis, Indiana, 46256, United States

  • Pd0060 50596

    Boca Raton, Florida, 33486, United States

  • Pd0060 50597

    Naples, Florida, 34105, United States

  • Pd0060 50598

    Englewood, Colorado, 80113, United States

  • Pd0060 50600

    Altamonte Springs, Florida, 32714, United States

  • Pd0060 50601

    Loma Linda, California, 92354, United States

  • Pd0060 50603

    Tampa, Florida, 33609, United States

  • Pd0060 50604

    Dayton, Ohio, 45449, United States

  • Pd0060 50605

    Port Orange, Florida, 32127, United States

  • Pd0060 50607

    Portland, Oregon, 97210, United States

  • Pd0060 50608

    Little Rock, Arkansas, 72205, United States

  • Pd0060 50610

    Newark, Delaware, 19713, United States

  • Pd0060 50612

    Raleigh, North Carolina, 27607, United States

  • Pd0060 50613

    Grand Rapids, Michigan, 49503, United States

  • Pd0060 50614

    New York, New York, 10021, United States

  • Pd0060 50615

    Boston, Massachusetts, 02118, United States

  • Pd0060 50616

    Aventura, Florida, 33180, United States

  • Pd0060 50619

    Rock Hill, South Carolina, 29732, United States

  • Pd0060 50620

    St. Petersburg, Florida, 33710, United States

  • Pd0060 50622

    Cleveland, Ohio, 44195, United States

  • Pd0060 50627

    North Dartmouth, Massachusetts, 02747, United States

  • Pd0060 50628

    New Haven, Connecticut, 06519, United States

  • Pd0060 50647

    DeLand, Florida, 32720, United States

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