Overnight Switch From Rasagiline To Safinamide (SWH-MAOB)

April 9, 2024 updated by: IRCCS San Raffaele Roma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00163
        • IRCCS San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients able to comprehend and provide consent form
  • Patients with idiopathic Parkinson's disease diagnosed according to the UK Brain Bank criteria
  • Patients in mid-to late stage of the disease (Hoehn & Yahr: between the stage 2 and 4 in on state).
  • Patients suffering from motor fluctuations
  • Patients must have a good response to levodopa in the opinion of the investigators (evaluated as improvement ≥ 30% of the UPDRS scores)
  • Stable dosage of antiparkinsonian medication for at least 4 weeks prior to study enrollment
  • Female patients in post-menopausal state; women of childbearing potential must use an acceptable method of contraception

Exclusion Criteria:

  • Atypical Parkinsonism
  • Any significant psychiatric, metabolic and systemic concomitant disease
  • Patients with clinically significant out of range laboratory values
  • Patients participating in a clinical trial in the last 6 weeks
  • Patients with moderate-severe cognitive decline not able to provide consent form
  • Patients currently lactating or pregnant or planning to become pregnant during the duration of the study
  • Patients for whom Xadago is contraindicated according to the current SmPC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Safinamide
Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD
Drug: Safinamide
Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD
Other Names:
  • Xadago

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Blood Pressure (BP)
Time Frame: through study completion, an average of 8 weeks
Monitoring of BP by 24-hour Holter (increase by >10 mmHg)
through study completion, an average of 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical change in UPDRS compared to baseline
Time Frame: through study completion, an average of 8 weeks
Unified Parkinson's Disease rating scale (UPDRS total score ranges between 0 - normal - to 199 points - severe)
through study completion, an average of 8 weeks
Clinical change in H&Y compared to baseline
Time Frame: through study completion, an average of 8 weeks
Hoehn and Yahr scale is a system for describing progress of Parkinson's disease (range between 1 -less affect- to 5-more affect)
through study completion, an average of 8 weeks
Clinical change in MoCA compared to baseline
Time Frame: through study completion, an average of 8 weeks
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment (ranges between 0-more affect- and 30-normal)
through study completion, an average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele Roma

Investigators

  • Principal Investigator: Fabrizio Stocchi, MD. PhD, IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 15, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP 05/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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