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New hope for Parkinson's patients: opicapone study targets motor fluctuations

NCT ID NCT07403799

Symptom relief Sponsor: Bial - Portela C S.A. 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Updated 2 times

Summary

This study looks at how well the drug opicapone works for people with Parkinson's disease who have early signs of motor fluctuations (times when movement symptoms change). About 200 adults in Italy will take the drug as part of their normal care. Researchers will check if patients feel better after 12 months using a simple questionnaire.

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.

Participants

200 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

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.

Who is studied

The study will be conducted at approximately 20 centers located in Italy and plans to enroll approximately 200 patients with Parkinson's Disease and early motor fluctuations.

Ages

30 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. The patient is able to comprehend and willing to provide written informed consent to participate in this study. 2. Patients aged 30 years or older. 3. The patient has a clinical diagnosis of PD according to the diagnostic criteria of United Kingdom (UK) PD Society Brain Bank (2006) or Movement Disorder Society (MDS) Clinical Criteria (2015). 4. Disease severity stages I-III (Hoehn \& Yahr Staging). 5. The patient is on treatment with levodopa/DOPA decarboxylase inhibitors (DDCI) for at least 1 year. 6. The patient has signs of wearing off phenomenon/end-of dose motor fluctuations for less than 2 years. 7. Patients starting treatment with opicapone as per local Summary of Product Characteristics (SmPC). Initiation of treatment with opicapone will be independent from participation in this observational study and must not be initiated for the purpose of study participation. The decision to treat patients with opicapone will occur before patients are enrolled in the study. Exclusion Criteria: 1. The patient has any form of Parkinsonism other than PD. 2. The patient is participating in a clinical trial with an investigational drug or has concluded participation within 30 days. 3. The patient has any contraindication to opicapone according to SmPC. 4. The patient meets criteria for dementia in the Investigator's judgment. 5. The patient is currently treated with catechol-O-methyl transferase (COMT) inhibitors.

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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

  • A.O.U Città della Salute e della Scienza di Torino

    Turin, 10126, Italy

  • ARNAS Azienda Ospedaliera Brotzu

    Cagliari, 09121, Italy

  • ASST Gaetano Pini CTO, Centro Parkinson

    Milan, 20126, Italy

  • ASST Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Arcispedale S. Maria Nuova (AUSL RE)

    Reggio Emilia, 42123, Italy

  • Azienda Ospedaliera di Perugia (Santa Maria della Misericordia)

    Perugia, 06100, Italy

  • Centro Neurolesi Bonino Pulejo Messina/IRCCS

    Messina, 98123, Italy

  • Fondazione Mondino

    Pavia, 27100, Italy

  • Istituto Neurologico Carlo Besta - Fondazione IRCCS

    Milan, 20133, Italy

  • Ospedale Borgo Roma

    Verona, 37134, Italy

  • Ospedale Mater Domini

    Catanzaro, 88100, Italy

  • Ospedale Policlinico San Martino

    Genova, 16132, Italy

  • Ospedale SS Annunziata

    Chieti, 66100, Italy

  • Ospedale Santa Chiara

    Pisa, 56126, Italy

  • Policlinico Tor Vergata

    Roma, 00133, Italy

  • Policlinico Umberto I

    Roma, 00161, Italy

  • Policlinico Universitario Campus Bio-Medico

    Roma, 00128, Italy

  • Policlinico Universitario Fondazione Agostino Gemelli

    Roma, 00168, Italy

  • Policlinico di Bari Ospedale Giovanni XXIII, Clinica Neurologia AMADUCCI

    Bari, 70124, Italy

  • U.O di Neurologia, Policlinico P. Giaccone

    Palermo, 90129, Italy

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