Parkinson DiseasePhase 4SWH-MAOBNCT03843944
Overnight Switch From Rasagiline To Safinamide
A Phase 4 study testing Safinamide in people with Parkinson Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Safinamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2018to 31 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Overnight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety Study
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
Read the 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
- Being tested
- Safinamide
- Keywords
- IMAO-B, Safinamide, Rasagiline
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafinamideDrug
Also called Xadago
Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD
| Study group | Role | What they receive |
|---|---|---|
| Safinamide | Experimental | Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD Receives: Drug: Safinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Blood Pressure (BP)
Monitoring of BP by 24-hour Holter (increase by >10 mmHg)
Measured: through study completion, an average of 8 weeks
Secondary outcomes (3)
Clinical change in UPDRS compared to baseline
Unified Parkinson's Disease rating scale (UPDRS total score ranges between 0 - normal - to 199 points - severe)
Measured: through study completion, an average of 8 weeks
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)
Measured: through study completion, an average of 8 weeks
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)
Measured: through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start1 May 2018
- Primary completion31 Mar 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrizio Stocchi, MD. PhD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843944
- Sponsor's protocol ID
- RP 05/17
- Acronym
- SWH-MAOB
- Status last verified
- Oct 2022
- First submitted
- 12 Feb 2019
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23196982Stocchi 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.
PubMed 21913224Marquet 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.
PubMed 22948897
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overnight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety Study
- ClinicalTrials.gov ID
- NCT03843944
- Acronym / sponsor ID
- SWH-MAOB / RP 05/17
- Conditions
- Parkinson Disease
- Keywords
- IMAO-B, Safinamide, Rasagiline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safinamide | Experimental | Drug: SafinamideOvernight switch from rasagiline 1 mg OD to safinamide 50 mg OD |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SafinamideAlso: XadagoOvernight switch from rasagiline 1 mg OD to safinamide 50 mg OD | Drug | Safinamide |
Primary outcome
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)
3 secondary outcomes
Clinical change in UPDRS compared to baseline
Time frame: through study completion, an average of 8 weeks
Clinical change in H&Y compared to baseline
Time frame: through study completion, an average of 8 weeks
Clinical change in MoCA compared to baseline
Time frame: through study completion, an average of 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 23196982Muller 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.
- Background: PubMed 21913224Stocchi 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.
- Background: PubMed 22948897Marquet 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrizio Stocchi, MD. PhD principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Safinamide in people with Parkinson Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Blood Pressure (BP) (time frame: through study completion, an average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03843944, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.