Overnight Switch From Rasagiline To Safinamide

NCT ID: NCT03843944

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-05-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Safinamide

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

Group Type: EXPERIMENTAL

Safinamide

Intervention Type: DRUG

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

Interventions

Safinamide

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

Intervention Type: DRUG

Other Intervention Names

Xadago

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele Roma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabrizio Stocchi, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele

Locations

IRCCS San Raffaele

Roma, , Italy

Countries

Italy

References

Muller T, Hoffmann JA, Dimpfel W, Oehlwein C. Switch from selegiline to rasagiline is beneficial in patients with Parkinson's disease. J Neural Transm (Vienna). 2013 May;120(5):761-5. doi: 10.1007/s00702-012-0927-3. Epub 2012 Nov 30.

Reference Type: BACKGROUND

PMID: 23196982 (View on PubMed)

Stocchi F, Borgohain R, Onofrj M, Schapira AH, Bhatt M, Lucini V, Giuliani R, Anand R; Study 015 Investigators. A randomized, double-blind, placebo-controlled trial of safinamide as add-on therapy in early Parkinson's disease patients. Mov Disord. 2012 Jan;27(1):106-12. doi: 10.1002/mds.23954. Epub 2011 Sep 12.

Reference Type: BACKGROUND

PMID: 21913224 (View on PubMed)

Marquet A, Kupas K, Johne A, Astruc B, Patat A, Krosser S, Kovar A. The effect of safinamide, a novel drug for Parkinson's disease, on pressor response to oral tyramine: a randomized, double-blind, clinical trial. Clin Pharmacol Ther. 2012 Oct;92(4):450-7. doi: 10.1038/clpt.2012.128. Epub 2012 Sep 5.

Reference Type: BACKGROUND

PMID: 22948897 (View on PubMed)

Other Identifiers

RP 05/17

Identifier Type: -

Identifier Source: org_study_id