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Multicenter, randomized, double-blind, parallel-group clinical trial to evaluate the efficacy and safety of Safinamide versus Rasagiline in fatigue associated with Parkinson's Disease.
EU CTIS ID: 2023-503713-29-00
What this study is testing
Evaluate the safety of Safinamide and Rasagiline administered for 6 months by measuring blood pressure (BP), heart rate (HR), blood tests, Movement Disorders Society Unified Parkinson's Disease Rating Scale part III (MDS UPDRS-III), ECG, and recording adverse effects.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects of both sexes aged between 50-80 years.
- Diagnosis of Parkinson´s Disease based on MDS criteria (Postuma, 2015) (45) with at least three years of Parkinson´s Disease duration, based on medical history and neurological examination.
- Neuroimaging compatible with Parkinson´s Disease.
- Hoehn and Yahr (H&Y) stage I-IV (included) during the 'ON' phase (Hohen, 1967).
- Presence of fatigue since at least one month prior to the initial visit defined by a mean Parkinson's Fatigue Scale (PFS) fatigue score ≥ 8 ((Brown et al. 2005; Stocchi et al. 2014; Niimi et al. 2019).
- Treatment with levodopa (alone or with other antiparkinsonian medications) at a stable dose for at least 4 weeks prior to the screening visit.
You likely can't join if
- A score of less than 23 on the MoCA global cognitive rating scale (Dalrymple-Alford, 1995).
- Current clinically significant or unstable medical illness (gastrointestinal, renal, hepatic, endocrine, pulmonary, cardiovascular, neoplastic, sleep disorders) that would preclude study participation or contribute to fatigue (such as anemia, active neoplasm, or hypothyroidism), as judged by the clinical judgment of the investigator.
- Treatment with Selegiline, Rasagiline, Safinamide (or any other MAO-B inhibitor) for at least 2 months prior to study inclusion.
- Hypersensitivity or intolerance to Rasagiline, Safinamide or any of their excipients.
- Any significant alteration in the anamnesis, examination, vital signs or laboratory tests that, in the investigator's opinion, contraindicate participation in the study.
- Severe motor complications (moderate-severe motor fluctuations defined as a score >1 on MDS UPDRS Part IV item 42; or disabling dyskinesias defined as a score >1 on MDS UPDRS Part IV item 36).
See the full eligibility criteria
Who can join
- Subjects of both sexes aged between 50-80 years.
- Diagnosis of Parkinson´s Disease based on MDS criteria (Postuma, 2015) (45) with at least three years of Parkinson´s Disease duration, based on medical history and neurological examination.
- Neuroimaging compatible with Parkinson´s Disease.
- Hoehn and Yahr (H&Y) stage I-IV (included) during the 'ON' phase (Hohen, 1967).
- Presence of fatigue since at least one month prior to the initial visit defined by a mean Parkinson's Fatigue Scale (PFS) fatigue score ≥ 8 ((Brown et al. 2005; Stocchi et al. 2014; Niimi et al. 2019).
- Treatment with levodopa (alone or with other antiparkinsonian medications) at a stable dose for at least 4 weeks prior to the screening visit.
- Subjects who can give written consent to participate in the study.
What rules you out
- A score of less than 23 on the MoCA global cognitive rating scale (Dalrymple-Alford, 1995).
- Current clinically significant or unstable medical illness (gastrointestinal, renal, hepatic, endocrine, pulmonary, cardiovascular, neoplastic, sleep disorders) that would preclude study participation or contribute to fatigue (such as anemia, active neoplasm, or hypothyroidism), as judged by the clinical judgment of the investigator.
- Treatment with Selegiline, Rasagiline, Safinamide (or any other MAO-B inhibitor) for at least 2 months prior to study inclusion.
- Hypersensitivity or intolerance to Rasagiline, Safinamide or any of their excipients.
- Any significant alteration in the anamnesis, examination, vital signs or laboratory tests that, in the investigator's opinion, contraindicate participation in the study.
- Severe motor complications (moderate-severe motor fluctuations defined as a score >1 on MDS UPDRS Part IV item 42; or disabling dyskinesias defined as a score >1 on MDS UPDRS Part IV item 36).
- History of Deep Brain Stimulation.
- Pregnancy, gestational desires, refusal to use adequate contraception, or breastfeeding.
- Insufficient level of Spanish or local language, illiteracy, sensory disturbances (vision, hearing), legal disability or any other mental, physical or social situation that prevents giving the informed consent form or adequately completing the evaluations.
- History or impression, at the investigator's discretion, of low therapeutic compliance.
- Active major psychiatric illness or with antipsychotic treatment: major hallucinations, with a score ≥3 on item 2 (thought disorder) of the MDS-UPDRS Section 1, severe Impulse Control disorder, major depression according to DSM (Diagnostic and Statistical Manual) and score ≥3 on item 3 of the MDS-UPDRS Section 1.
- Patients with diagnostic criteria for Apathy with a score ≥3 on item 4 of the MDS-UPDRS Section 1.
- Current diagnosis of substance abuse or history of alcohol or drug abuse in the 3 months prior to the initial visit.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.