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Overnight Switch From Rasagiline To Safinamide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03843944
Recruitment Status : Completed
First Posted : February 18, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Fabrizio Stocchi, MD, PhD, IRCCS San Raffaele

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Safinamide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Overnight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety Study
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Safinamide
Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD
Drug: Safinamide
Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD
Other Name: Xadago




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843944


Locations
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Italy
IRCCS San Raffaele
Roma, Italy, 00163
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
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Principal Investigator: Fabrizio Stocchi, MD. PhD IRCCS San Raffaele
Publications:
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Responsible Party: Fabrizio Stocchi, MD, PhD, full professor, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03843944    
Other Study ID Numbers: SWH-MAOB
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fabrizio Stocchi, MD, PhD, IRCCS San Raffaele:
IMAO-B
Safinamide
Rasagiline
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases