Independent, multicenter, phase IV, randomized, double-blind, parallel-group clinical trial in people with Parkinson's Disease under stable dopaminergic treatment with persistent fatigue symptoms, randomized 1:1 to adjunctive treatment with safinamide (100 mg/day) or rasagiline (1 mg/day) for 24 weeks.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503713-29-00

Acronym

IIBSP-FAT-2023-24

Enrollment

Registered

2023-09-07

Start date

2023-12-13

Completion date

Unknown

Last updated

2025-07-23

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

Conditions

Fatigue symptoms associated with Parkinson´s Disease.

Brief summary

Changes in the Fatigue Severity Scale (FSS) score.

Interventions

DRUGSAFINAMIDE

DRUGRASAGILINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Changes in the Fatigue Severity Scale (FSS) score.	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026