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Overnight Switch From Rasagiline To Safinamide

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Safinamide
Sponsored by
IRCCS San Raffaele Roma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring IMAO-B, Safinamide, Rasagiline

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS San Raffaele

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Safinamide

Arm Description

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

Outcomes

Primary Outcome Measures

Change From Baseline in Blood Pressure (BP)
Monitoring of BP by 24-hour Holter (increase by >10 mmHg)

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2019
Last Updated
October 17, 2022
Sponsor
IRCCS San Raffaele Roma
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1. Study Identification

Unique Protocol Identification Number
NCT03843944
Brief Title
Overnight Switch From Rasagiline To Safinamide
Official Title
Overnight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele Roma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
IMAO-B, Safinamide, Rasagiline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safinamide
Arm Type
Experimental
Arm Description
Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD
Intervention Type
Drug
Intervention Name(s)
Safinamide
Other Intervention Name(s)
Xadago
Intervention Description
Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD
Primary Outcome Measure Information:
Title
Change From Baseline in Blood Pressure (BP)
Description
Monitoring of BP by 24-hour Holter (increase by >10 mmHg)
Time Frame
through study completion, an average of 8 weeks
Secondary Outcome Measure Information:
Title
Clinical change in UPDRS compared to baseline
Description
Unified Parkinson's Disease rating scale (UPDRS total score ranges between 0 - normal - to 199 points - severe)
Time Frame
through study completion, an average of 8 weeks
Title
Clinical change in H&Y compared to baseline
Description
Hoehn and Yahr scale is a system for describing progress of Parkinson's disease (range between 1 -less affect- to 5-more affect)
Time Frame
through study completion, an average of 8 weeks
Title
Clinical change in MoCA compared to baseline
Description
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment (ranges between 0-more affect- and 30-normal)
Time Frame
through study completion, an average of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrizio Stocchi, MD. PhD
Organizational Affiliation
IRCCS San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS San Raffaele
City
Roma
ZIP/Postal Code
00163
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23196982
Citation
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.
Results Reference
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PubMed Identifier
21913224
Citation
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.
Results Reference
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PubMed Identifier
22948897
Citation
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.
Results Reference
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Overnight Switch From Rasagiline To Safinamide

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