Study to verify safety and tolerability of the immediate switch from rasagiline (irreversible MAO-B inhibitor) and safinamide (reversible inhibitor of MAO-B)

OVERNIGHT SWITCH FROM RASAGILINE TO SAFINAMIDE IN FLUCTUATING PATIENTS WITH PARKINSON’S DISEASE: A TOLERABILITY AND SAFETY STUDY - OVERNIGHT SWITCH FROM RASAGILINE TO SAFINAMIDE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000973-19-IT

Enrollment

Registered

2022-01-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease MedDRA version: 21.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 100000004852

Interventions

Trade Name: XADAGO - 50 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- 30 COMPRESSE Product Name: Xadago Product Code: N04BD03 Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Male and female of age between 30 an 80 yrs old. •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 •Patiens 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 enrolment •Female patients in post-menopausal state with at least one year absence of vaginal bleeding or spotting or be surgically sterile •Women of childbearing potential must use an acceptable method of contraception •men with a potentially fertile partner must have had a vasectomy or be willing to use an acceptable method of contraception for the duration of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: •Atypical Parkinsonism •Any significant psychiatric, metabolic and systemic significant concomitant disease •Patients with Liver failure •Patients with clinically significant out of range laboratory values in the anamnesis •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

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to verify safety and tolerability of the immediate switch from rasagiline (irreversible MAO-B inhibitor) and safinamide (reversible MAO-B inhibitor) 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. The mean blood pressure (MAP) is the average blood pressure in an individual. It is defined as the average arterial pressure during a single cardiac cycle.;Secondary Objective: Secondary endpoints will be: a) clinical change compared to baseline at the following scales: - Unified Parkinson's Disease rating scale (total score), - Hoehn &Yahr, - Montreal Cognitive assessment (MoCA) - Abnormal involuntary Movement Scale (AIMS); b) variability of MAP that will be correlated with patients’ clinical status (on and off state). ;Primary end point(s): The primary objective of the study will be achieved if the mean BP will not increase by >10 mmHg in the studied population. The mean blood pressure (MAP) is the average blood pressure in an individual. It is defined as the average arterial pressure during a single cardiac cycle.;Timepoint(s) of evaluation of this end point: End of study	—

Measure

Time frame

Main Objective: The aim of this study is to verify safety and tolerability of the immediate switch from rasagiline (irreversible MAO-B inhibitor) and safinamide (reversible MAO-B inhibitor) 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. The mean blood pressure (MAP) is the average blood pressure in an individual. It is defined as the average arterial pressure during a single cardiac cycle.;Secondary Objective: Secondary endpoints will be: a) clinical change compared to baseline at the following scales: - Unified Parkinson's Disease rating scale (total score), - Hoehn &Yahr, - Montreal Cognitive assessment (MoCA) - Abnormal involuntary Movement Scale (AIMS); b) variability of MAP that will be correlated with patients’ clinical status (on and off state). ;Primary end point(s): The primary objective of the study will be achieved if the mean BP will not increase by >10 mmHg in the studied population. The mean blood pressure (MAP) is the average blood pressure in an individual. It is defined as the average arterial pressure during a single cardiac cycle.;Timepoint(s) of evaluation of this end point: End of study

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints will be: a) clinical change compared to baseline at the following scales: - Unified Parkinson's Disease rating scale (total score), - Hoehn &Yahr, - Montreal Cognitive assessment (MoCA) - Abnormal involuntary Movement Scale (AIMS); b) variability of MAP that will be correlated with patients’ clinical status (on and off state). ;Timepoint(s) of evaluation of this end point: End of study	—

Measure

Time frame

Secondary end point(s): Secondary endpoints will be: a) clinical change compared to baseline at the following scales: - Unified Parkinson's Disease rating scale (total score), - Hoehn &Yahr, - Montreal Cognitive assessment (MoCA) - Abnormal involuntary Movement Scale (AIMS); b) variability of MAP that will be correlated with patients’ clinical status (on and off state). ;Timepoint(s) of evaluation of this end point: End of study

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Countries

Italy

Contacts

Public ContactClinical Trial Centre

IRCCS SAN RAFFAELE PISANA GESTITO DA SAN RA

fabrizio.stocchi@sanraffaele.it06.52252311

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026