Study on Safinamide and Rasagiline for Treating Fatigue in Parkinson’s Disease Patients on Stable Dopaminergic Treatment

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What is this study about?

This clinical trial is focused on studying Parkinson’s Disease, a condition that affects movement and often includes symptoms like tremors, stiffness, and difficulty with balance and coordination. The study specifically looks at people with Parkinson’s Disease who experience persistent fatigue, which is a common symptom that can significantly impact daily life. The trial will compare two treatments: Safinamide and Rasagiline. Both are medications taken orally in tablet form and are used to help manage symptoms of Parkinson’s Disease.

The purpose of the study is to evaluate the safety and effectiveness of these two medications in reducing fatigue associated with Parkinson’s Disease. Participants will be randomly assigned to receive either Safinamide at a dose of 100 mg per day or Rasagiline at a dose of 1 mg per day. The study will last for 24 weeks, during which time participants will continue their usual Parkinson’s treatment while adding one of these medications. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know which medication each participant is receiving, to ensure unbiased results.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their symptoms. This will include measuring blood pressure, heart rate, and conducting blood tests. Additionally, participants will be assessed using the Movement Disorders Society Unified Parkinson’s Disease Rating Scale part III (MDS UPDRS-III), which helps evaluate the severity of Parkinson’s symptoms. The study aims to provide valuable information on how these medications can help manage fatigue in people with Parkinson’s Disease.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of Parkinson’s Disease, and presence of fatigue symptoms.

Written consent is required to participate in the study.

2 randomization

Participants are randomly assigned to one of two groups: one group receives safinamide (100 mg per day) and the other group receives rasagiline (1 mg per day).

The assignment is double-blind, meaning neither the participants nor the researchers know which treatment is being administered to each participant.

3 treatment phase

The treatment lasts for 24 weeks, during which the assigned medication is taken orally every day.

Participants continue their stable dopaminergic treatment alongside the study medication.

4 monitoring and assessments

Throughout the study, various health parameters are monitored, including blood pressure, heart rate, and results from blood tests.

The Movement Disorders Society Unified Parkinson’s Disease Rating Scale part III (MDS UPDRS-III) is used to assess motor symptoms.

Electrocardiograms (ECG) are conducted, and any adverse effects are recorded.

5 evaluation of outcomes

The primary outcome is measured by changes in the Fatigue Severity Scale (FSS) score.

The study aims to evaluate the safety and efficacy of the medications in reducing fatigue associated with Parkinson’s Disease.

Who Can Join the Study?

  • Participants can be of any gender and must be between 50 and 80 years old.
  • Participants must have been diagnosed with Parkinson’s Disease for at least three years. This diagnosis should be based on specific criteria and confirmed by a medical history and a neurological exam.
  • Participants must have brain scans that are consistent with Parkinson’s Disease.
  • Participants should be in stages I to IV of the Hoehn and Yahr scale during their “ON” phase. This scale measures the severity of Parkinson’s Disease.
  • Participants must have experienced fatigue for at least one month before the first visit. This is measured by a specific fatigue scale, and the score should be 8 or higher.
  • Participants should be on a stable dose of levodopa (a common medication for Parkinson’s Disease) either alone or with other medications for at least four weeks before the screening visit.
  • Participants must be able to provide written consent to join the study.

Who Cannot Join the Study?

  • Patients who are not experiencing fatigue symptoms related to Parkinson’s Disease cannot participate.
  • Individuals who are not within the specified age range for the study are excluded.
  • Participants who do not meet the gender requirements for the study are not eligible.
  • People who are considered part of a vulnerable population are not allowed to join the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital General Universitario De Elche Elche Spain
Hospital General Universitario Santa Lucia Cartagena Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Hoyqrixx Urjbcbftclrwq Drbykdlx Donostia / San Sebastian Spain
Hxuyphct Df Lz Shlwn Cpxs I Svzg Pto Barcelona Spain
Hbiprlys Ulakazzouixaq ds A Cwpltl A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.09.2023

Trial locations

Investigated drugs:

Safinamide is a medication used in this trial as an additional treatment for people with Parkinson’s Disease who are already on stable dopaminergic therapy but still experience persistent fatigue. It is being tested to see if it can help improve symptoms when taken daily for 24 weeks.

Rasagiline is another medication being tested in this trial. Like Safinamide, it is used as an additional treatment for Parkinson’s Disease patients who continue to experience fatigue despite stable dopaminergic therapy. The trial aims to evaluate its safety and effectiveness over a 24-week period.

Parkinson’s Disease – Parkinson’s Disease is a progressive neurological disorder that affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. Over time, individuals may experience a slowing of movement and changes in speech and writing. Fatigue is a common symptom associated with Parkinson’s Disease, impacting daily activities and quality of life. The disease progresses gradually, with symptoms worsening over time.

Trial ID:
2023-503713-29-00
Protocol code:
IIBSP-FAT-2023-24
Trial Phase:
Therapeutic confirmatory (Phase III)

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