Effects of Safinamide therapy on reuroplasticity in patients with Parkinson's disease

Effects of Safinamide therapy on reuroplasticity in patients with Parkinson's disease - Safinamide's therapy on pd patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002239-41-IT

Enrollment

Registered

2021-06-08

Start date

2018-02-16

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: XADAGO - 50 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- 30 COMPRESSE Product Name: Xadago 50mg Product Code: NO4BD03 Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All PD patients will have to show a moderate level of Parkinson's disease as assested by Hoehn and Yahr stage (ranging from 1 to 4) during off drug condition; aged 30 to 80 years. Women of child-bearing age may be enrolled - those after menarche and up to post-menopause if not permanently sterile. The methods of permanent sterilization include hysterectomy, bilateral salpingotomy and bilateral oophorectomy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Patients with evidence of dementia, major psychiatric illnesses, and/or severe and progressive medical illnesses, with controindications to TMS were included. Also excluded: pregnant and lactating women, patients with hypersensitivity to the active substance or to any of the excipients, patients receiving concomitant treatment with other mono-aminase oxidase inhibitors (MAO), patients receiving concomitant treatment with pethidine. Finally, it will not be allowed to use in patients with severe hepatic impairment or with albinism, retinal degeneration, uveitis, hereditary retinopathy or severe progressive diabetic retinopathy.

Design outcomes

Primary

Measure	Time frame
Main Objective: To access how safinamide changes neuroplasticity in patients with Parkinson's disease;Secondary Objective: To verify the clinical impact of safinamide in patients with Parkinson's disease;Primary end point(s): Percentage change from baseline to endpoint of LTP-like cortical plasticity calculated as increase/decrese of MEP amplitude following iTBS.;Timepoint(s) of evaluation of this end point: 1 year	—

Measure

Time frame

Main Objective: To access how safinamide changes neuroplasticity in patients with Parkinson's disease;Secondary Objective: To verify the clinical impact of safinamide in patients with Parkinson's disease;Primary end point(s): Percentage change from baseline to endpoint of LTP-like cortical plasticity calculated as increase/decrese of MEP amplitude following iTBS.;Timepoint(s) of evaluation of this end point: 1 year

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in comperison to the baseline (decrease of the total score >/= 1) in UPDRS scale and improvement or worsening of the CGI scale.;Timepoint(s) of evaluation of this end point: 1 year	—

Countries

Italy

Contacts

Public ContactUnit¿ di stimolazione cerebrale non

Fondazione Santa Lucia

g.koch@hsantalucia.it0651501181

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026