Overnight Switch From Rasagiline To Safinamide

NCT03843944 | Completed Phase 4

• 1 other identifier: RP 05/17
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease

Keywords

IMAO-B; Safinamide; Rasagiline

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Blood Pressure (BP)

  Monitoring of BP by 24-hour Holter (increase by \>10 mmHg)

  through study completion, an average of 8 weeks

Secondary Outcomes (3)

• Clinical change in UPDRS compared to baseline

  through study completion, an average of 8 weeks

• Clinical change in H&Y compared to baseline

  through study completion, an average of 8 weeks

• Clinical change in MoCA compared to baseline

  through study completion, an average of 8 weeks

Study Arms (1)

Safinamide

EXPERIMENTAL

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

Drug: Safinamide

Interventions

Safinamide DRUG

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

Also known as: Xadago

Safinamide

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCS San Raffaele

Roma, 00163, Italy

Location

Related Publications (3)

• 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.

  PMID: 23196982 BACKGROUND

• 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.

  PMID: 21913224 BACKGROUND

• 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.

  PMID: 22948897 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

safinamide

Condition Hierarchy (Ancestors)

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

Study Officials

• Fabrizio Stocchi, MD. PhD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 18, 2019
• Study Start: May 1, 2018
• Primary Completion: March 31, 2019
• Study Completion: May 31, 2019
• Last Updated: April 10, 2024

Record last verified: 2022-10

Locations

IT (1)