Effects of safinamide mesylate on neuroplasticity in patients with Parkinson's disease

JRCT ID: jRCTs061220070

Registered date:15/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 19/04/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Evaluation of neuroplasticity by nerve stimulation

Outcome(s)

• Primary Outcome: Induction of neural plasticity (LTP-like effect) induced by non-invasive brain stimulation of the cerebral cortex (motor area)

Secondary Outcome

1) Relationship between Parkinson's disease clinical symptom score, ratio of motor evoked potentials (LTP-like effect) and motor cortex excitability index
2) Relationship between therapeutic drugs and Parkinson's disease clinical symptom score, motor evoked potential ratio (LTP-like effect), and motor cortex excitability index
3) Adversed experience

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

[Parkinson's disease group]
1) Patients diagnosed with Parkinson's disease according to the diagnostic criteria of the Parkinson's disease clinical practice guidelines 2018
2) Patients considering initiation of safinamide mesilate concomitant administration in routine practice
3) Patients between the ages of 20 and 90

[Healthy volunteer group]
1) Subjects who are age- and sex-matched with those enrolled in the Parkinson's disease group
2) Subjects who are judged to be in good health by the investigator or co-investigator, with no abnormalities in subjective symptoms or objective findings in examinations and observations at the start of the study.

Exclude criteria

[Parkinson's disease group]
1) Patients with contraindications to safinamide mesylate
2) Patients with safety risks associated with transcranial magnetic stimulation
3) Patients judged to require administration of other Parkinson's disease drugs from the levodopa monotherapy period (from the time of informed consent) to the completion of the safinamide mesilate combination period. Patients receiving anticholinergics or amantadine hydrochloride could be enrolled if the dosage is not changed during the study.

[Healthy volunteer group]
1) Subjects with safety risks associated with transcranial magnetic stimulation
2) Illicit drug users or alcoholics
3) Subjects with a history or symptoms of neurological/psychiatric disorders
4) Subjects who take medication for neurological/psychiatric disorders
5) Subjects with serious illness

Related Information

• Primary Sponsor: Hanajima Ritsuko
• Source(s) of Monetary Support: Eisai Co.