NCT03843944

Overnight Switch From Rasagiline To Safinamide

Overnight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: IRCCS San Raffaele Roma · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Rasagiline label report the indication to wait at least 14 days between discontinuation of rasagiline and initiation of another MAO inhibitor. This results in a major inconvenience for Parkinsonian patients (PD) due to their clinical worsening. Safinamide is a reversible MAO-B inhibitor, characterized by a good safety profile. In clinical practice safinamide is often introduced instead of rasagiline following an overnight switch. The aim of this study is to explore the safety and tolerability of the immediate switch from rasagiline (irreversible MAO-B inhibitor) to safinamide, with the expectation that there will be no adverse events or increased risk of hypertensive crisis for patients with PD or signs of serotonin syndrome

Detailed description

Objective: The aim of this study is to verify safety and tolerability of the immediate switch from rasagiline to safinamide trough monitoring of BP by 24-hour Holter recording. The primary objective of the study will be achieved if the mean BP will not increase by \>10 mmHg in the studied population. Methods: This is an open-label, single-centre study conducted at IRCCS San Raffaele Pisana. Study population included patients with idiopathic PD in the mid-late stage of the disease, suffering from motor fluctuation, on stable treatment with rasagiline and Levodopa (alone or in combination with other anti-parkinsonian medication). The protocol contemplates five visits during six weeks, with two 24-hour Holter recording (first in rasagiline and second in first-day of safinamide therapy), monitoring typical symptoms of the serotonin syndrome.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Safinamide	Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-03-31
• Completion: 2019-05-31
• First posted: 2019-02-18
• Last updated: 2024-04-10

Locations

1 site across 1 country: Italy