CLINICAL TRIALS PROFILE FOR XADAGO

All Clinical Trials for XADAGO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02495831 ↗	Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers	Completed	Cross Research S.A.	Phase 1	2015-05-01	To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with respect to 50 mg diclofenac sodium administered alone.
NCT02495831 ↗	Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers	Completed	Zambon SpA	Phase 1	2015-05-01	To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with respect to 50 mg diclofenac sodium administered alone.
NCT03216304 ↗	Safinamide Steady State Interaction With Rosuvastatin	Completed	Zambon SpA	Phase 1	2017-05-22	To evaluate if safinamide at the steady state, obtained after multiple 100 mg once a day administrations, has an effect on the pharmacokinetics of rosuvastatin, concomitantly administered as a single 20 mg dose, with respect to the pharmacokinetics of 20 mg rosuvastatin administered alone.
NCT03216304 ↗	Safinamide Steady State Interaction With Rosuvastatin	Completed	Cross Research S.A.	Phase 1	2017-05-22	To evaluate if safinamide at the steady state, obtained after multiple 100 mg once a day administrations, has an effect on the pharmacokinetics of rosuvastatin, concomitantly administered as a single 20 mg dose, with respect to the pharmacokinetics of 20 mg rosuvastatin administered alone.
NCT03753763 ↗	Safinamide for Multiple System Atrophy (MSA)	Completed	Zambon SpA	Phase 2	2019-10-29	The study is a placebo controlled study, with two parallel arms, in which participants will be randomly assigned in a 2:1 ratio to receive either active (200 mg safinamide) or placebo in a double blind manner. Study population is patients diagnosed, with possible or probable parkinsonian variant of Multiple System Atrophy who are on a stable treatment of levodopa
NCT03843944 ↗	Overnight Switch From Rasagiline To Safinamide	Completed	IRCCS San Raffaele	Phase 4	2018-05-01	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

Clinical Trial Conditions for XADAGO

Condition Name

Condition Name for XADAGO
Intervention	Trials
Healthy	2
Parkinson Disease	1
Idiopathic Parkinson's Disease (at Later Stage)	1
Multiple System Atrophy	1

Condition MeSH

Condition MeSH for XADAGO
Intervention	Trials
Parkinson Disease	2
Shy-Drager Syndrome	1
Multiple System Atrophy	1
Atrophy	1

Clinical Trial Locations for XADAGO

Trials by Country

Trials by Country for XADAGO
Location	Trials
Switzerland	3
Italy	2
Spain	1

Clinical Trial Progress for XADAGO

Clinical Trial Phase

Clinical Trial Phase for XADAGO
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for XADAGO
Clinical Trial Phase	Trials
Completed	4
Recruiting	1

Clinical Trial Sponsors for XADAGO

Sponsor Name

Sponsor Name for XADAGO
Sponsor	Trials
Zambon SpA	3
Cross Research S.A.	2
Alain Kaelin	1

Sponsor Type

Sponsor Type for XADAGO
Sponsor	Trials
Industry	5
Other	3