NCT06432309Completed
Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease
Efficacy and Safety of Opicapone in Parkinson's Disease Add -on to Levodopa Carbidopa Intestinal Gel
Source: ClinicalTrials.gov · Last updated 3 Mar 2025
Brief summary (registry, in English)
Levodopa-Carbidopa intestinal gel (LCIG) is an effective therapy for complicated Parkinson's disease (PD). Few studies have explored the efficacy and safety of the potential combination of LCIG with catechol-O-methyltransferase (COMT) inhibitors, particularly Opicapone (OPC).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 7 May 2024
- Start date
- 1 Jul 2022
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University Hospital of Ferrara
- Diseases
- Parkinson disease
- NCT number
- NCT06432309
What you commit to
- Study type: Interventional
- Participants enrolled: 22
- From 1 Jul 2022 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Hoehn \& Yahr (H\&Y) \>4,
- Cognitive decline (MOCA\< 17),
- more than 30 months after LCIG positioning,
- not compliant with treatment and follow-up visits.
Who the study is looking for
- LCIG implantation not longer than 30 months before the study enrollment,
- Presence of nocturnal akinesia (assessed by medical history and through item 2.9 of MDS-UPDRS part II (\> 2), or/and
- Persistence of morning or afternoon akinesia (assessed by item 4.3 in MDS UPDRS -IV( \>2 ).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Ferrara - Arcispedale Sant'Anna Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.