Status:
COMPLETED
Overnight Switch From Rasagiline To Safinamide
Lead Sponsor:
IRCCS San Raffaele Roma
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
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 pa...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03843944
Start Date
May 1 2018
End Date
May 31 2019
Last Update
April 10 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IRCCS San Raffaele
Roma, Italy, 00163