Hospital Clinico San Carlos
Madrid, Spain
Rare diseases
Investigational molecules
Locations
A plain-language summary of the goals, design and what participants do
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.
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
7 criteria
4 criteria
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Madrid, Spain
Barcelona, Spain
Donostia / San Sebastian, Spain
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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.
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.
Safinamide is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating fatigue symptoms associated with Parkinson's Disease. It is an approved medication used as an add-on treatment for patients already on stable dopaminergic therapy. Safinamide works by inhibiting monoamine oxidase B (MAO-B) and modulating glutamate release, which helps to increase dopamine levels in the brain and improve motor function. It is classified as a selective MAO-B inhibitor.
Rasagiline is also administered orally in tablet form and is being evaluated in clinical trials for its role in managing fatigue symptoms in Parkinson's Disease. It is an established medication used as an adjunct therapy for patients on stable dopaminergic treatment. Rasagiline functions by selectively inhibiting monoamine oxidase B (MAO-B), leading to increased dopamine levels in the brain, which can enhance motor control. It belongs to the pharmacological class of selective MAO-B inhibitors.
sourced from the EU Clinical Trials Register and site verification
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