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NCT Number: NCT03843944

Overnight Switch From Rasagiline To Safinamide

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IRCCS San Raffaele

Roma, 00163, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Safinamide

Drug

Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD

Other names: Xadago

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele Roma

Other

Registry information

Official study title

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

Acronym: SWH-MAOB

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 18, 2019
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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