---
title: Reduce wearing off motor fluctuations
nct_id: NCT07403799
status: RECRUITING
sponsor: Bial - Portela C S.A.
study_type: OBSERVATIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07403799"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07403799"
last_fetched: "2026-05-10T14:06:04.216Z"
source: "Parkinson's Pathways (curated)"
---
# Reduce wearing off motor fluctuations

**Goal (in five words):** Reduce wearing off motor fluctuations

**Official Title:** Real-life, Observational Study on Opicapone in Patients With Parkinson's Disease and Early Motor Fluctuations in Italy

**Trial ID:** [NCT07403799](https://clinicaltrials.gov/study/NCT07403799)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Sponsor:** Bial - Portela C S.A.
- **Target Enrollment:** 200 participants
- **Start Date:** 2025-07-08
- **Completion Date:** 2028-10-31
- **Conditions:** Parkinson Disease
- **Interventions:** Opicapone 50 mg
- **Intervention Types:** DRUG

## Summary For Families

The goal is to see how opicapone works in real-life care to reduce early end-of-dose wearing off and cut down OFF time for people with Parkinson's. Opicapone 50 mg is a once daily peripheral COMT inhibitor, it slows the enzyme that breaks down levodopa outside the brain so levodopa stays available longer and on-time is extended; patients join after their doctor has already decided to start the drug. They are looking for adults 30 and older with PD (Hoehn and Yahr stages I to III) who have been on levodopa at least one year, have had wearing-off for less than two years, and who are not already on a COMT inhibitor or judged to have dementia or other forms of parkinsonism.

## Eligibility

- **Minimum age:** 30 Years
- **Sex:** ALL

### Full Criteria

```
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.
```

## Locations (20)

- Policlinico di Bari Ospedale Giovanni XXIII, Clinica Neurologia AMADUCCI, Bari, Italy _(41.1207, 16.8698)_
  - Giovanni Defazio — (CONTACT)
- ASST Spedali Civili di Brescia, Brescia, Italy _(45.5356, 10.2147)_
  - Andrea Pilotto — (CONTACT)
- ARNAS Azienda Ospedaliera Brotzu, Cagliari, Italy _(39.2305, 9.1192)_
  - Giovanni Cossu — (CONTACT)
- Ospedale Mater Domini, Catanzaro, Italy _(38.8825, 16.6009)_
  - Maurizio Morelli — (CONTACT)
- Ospedale SS Annunziata, Chieti, Italy _(42.3483, 14.1649)_
  - Stefano Sensi — (CONTACT)
- Ospedale Policlinico San Martino, Genova, Italy _(45.2160, 11.8721)_
  - Roberta Marchese — (CONTACT)
- Centro Neurolesi Bonino Pulejo Messina/IRCCS, Messina, Italy _(38.1939, 15.5526)_
  - Angelo Quartarone — (CONTACT)
- ASST Gaetano Pini CTO, Centro Parkinson, Milan, Italy _(45.4643, 9.1895)_
  - Salvatore Bonvegna — (CONTACT)
- Istituto Neurologico Carlo Besta - Fondazione IRCCS, Milan, Italy _(45.4643, 9.1895)_
  - Roberto Cilia — (CONTACT)
- U.O di Neurologia, Policlinico P. Giaccone, Palermo, Italy _(38.1166, 13.3636)_
  - Marco D'Amelio — (CONTACT)
- Fondazione Mondino, Pavia, Italy _(45.1921, 9.1592)_
  - Micol Avenali — (CONTACT)
- Azienda Ospedaliera di Perugia (Santa Maria della Misericordia), Perugia, Italy _(43.1122, 12.3888)_
  - Nicola Tambasco — (CONTACT)
- Ospedale Santa Chiara, Pisa, Italy _(43.7085, 10.4036)_
  - Roberto Ceravolo — (CONTACT)
- Arcispedale S. Maria Nuova (AUSL RE), Reggio Emilia, Italy _(44.6983, 10.6312)_
  - Francesco Cavallieri — (CONTACT)
- Policlinico Universitario Campus Bio-Medico, Roma, Italy _(44.9936, 11.1064)_
  - Massimo Marano — (CONTACT)
- Policlinico Tor Vergata, Roma, Italy _(44.9936, 11.1064)_
  - Mariangela Pierantozzi — (CONTACT)
- Policlinico Umberto I, Roma, Italy _(44.9936, 11.1064)_
  - Giovanni Fabbrini — (CONTACT)
- Policlinico Universitario Fondazione Agostino Gemelli, Roma, Italy _(44.9936, 11.1064)_
  - Annarita Bentivoglio — (CONTACT)
- A.O.U Città della Salute e della Scienza di Torino, Turin, Italy _(45.0705, 7.6868)_
  - Leonardo Lopiano — (CONTACT)
- Ospedale Borgo Roma, Verona, Italy _(45.4385, 10.9938)_
  - Michele Tinazzi — (CONTACT)

## Central Contacts

- Daniela Cigognini — (CONTACT) — +39 3455430205 — daniela.cigognini@bial.com
- Ruben Arnelas — (CONTACT) — +351229866100 — ruben.arnelas@bial.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT07403799*  
*HTML version: https://parkinsonspathways.com/trial/NCT07403799*  
*Source data: https://clinicaltrials.gov/study/NCT07403799*