Study on the Safety and Effects of Fasudil Hydrochloride for Patients with Parkinson’s Disease

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Parkinson’s Disease, a condition that affects movement and can cause tremors, stiffness, and difficulty with balance and coordination. The treatment being tested is called Fasudil Hydrochloride, which is taken as an oral solution. The study aims to understand the safety and how well patients tolerate this treatment over a period of 22 days. The trial will also explore how the treatment affects symptoms of Parkinson’s Disease.

Participants in the study will receive either a high dose or a low dose of Fasudil Hydrochloride, or a placebo. The study will monitor participants for any side effects and changes in their condition. The goal is to gather information on how the treatment impacts the symptoms and overall quality of life for those with Parkinson’s Disease. The study will also include assessments using various scales to measure changes in symptoms and quality of life.

Throughout the study, participants will be observed for any adverse effects, and their progress will be tracked using different evaluation tools. These tools include the MDS-Unified Parkinson’s Disease Rating Scale, which helps measure the severity of symptoms, and the PD Quality of Life Scale, which assesses the impact of the disease on daily living. The study will provide valuable insights into the potential benefits and risks of using Fasudil Hydrochloride as a treatment for Parkinson’s Disease.

1 introduction to the trial

Upon joining the study, the patient receives detailed information about the trial’s purpose, which is to assess the safety and tolerability of the oral solution of fasudil in individuals with Parkinson’s disease over a period of 22 days.

The patient is informed about the eligibility criteria, which include having a diagnosis of Parkinson’s disease, being between the ages of 30 and 80, and being stable on current Parkinson’s medication for at least six weeks.

2 medication administration

The patient begins taking the fasudil hydrochloride oral solution. The dosage and frequency are determined by the study protocol, which includes both high and low doses.

The medication is taken orally, and the patient is monitored for any side effects or adverse reactions throughout the 22-day period.

3 monitoring and assessments

During the trial, the patient undergoes regular assessments to monitor the effects of the medication. These assessments include checking vital signs and laboratory tests to identify any treatment-related adverse events.

The patient completes various questionnaires and scales, such as the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), the PD Quality of Life Scale (PDQ-8), and the Non-Motor Symptom Questionnaire (NMSQuest), to evaluate changes in symptoms and quality of life.

4 follow-up evaluations

After the initial 22-day period, the patient continues to be evaluated at specific intervals, including day 50, to assess the longer-term effects of the treatment.

These evaluations include further assessments of symptoms, quality of life, and any ongoing side effects.

5 completion of the trial

At the end of the trial, the patient receives a final evaluation to summarize the findings related to their participation.

The patient is informed about the overall results of the trial and any implications for future treatment options.

Who Can Join the Study?

Patients must have a diagnosis of at least probable Parkinson’s Disease (PD) according to specific criteria.
Patients should be in Hoehn & Yahr stage 1 – 3, which is a scale used to describe the progression of Parkinson’s Disease.
Patients must not have symptoms that fluctuate, meaning no “wearing-off” or involuntary movements called dyskinesia, and should be stable on their Parkinson’s medication for at least 6 weeks.
Patients should be between the ages of 30 and 80 years.
Women who can have children must not be breastfeeding, must be surgically sterile or using a highly effective birth control method, and must have a negative pregnancy test. Effective birth control methods include implants, injections, birth control pills, hormonal devices placed in the uterus, not having sex, or having a partner who has had a vasectomy.
Patients must be able to fully understand all the information provided and give their full informed consent, which means they agree to participate in the study after understanding all the details.

Who Cannot Join the Study?

Patients who have a different condition than Idiopathic Parkinson’s Disease cannot participate. This means the study is only for those with this specific type of Parkinson’s Disease.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who are not able to take oral medication, which means medicine taken by mouth, cannot participate.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients who have participated in another clinical trial recently may not be eligible. This is to avoid any interference with the study results.
Patients with certain medical conditions that might interfere with the study or pose a risk to their health cannot participate.
Patients who are unable to follow the study procedures or instructions cannot participate. This is important for the accuracy and safety of the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Philipps-Universitaet Marburg	Marburg	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Ujfirinzmzghflzxaigae Dwtiuzpcmxa Aah	Duesseldorf	Germany
Upnzklfngcedgrymozsrx Mjrighyq Aqi	Munster	Germany
Uaxtexbhakaqtemnshhvb Wourlqedl Ala	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.04.2023

Trial locations

Investigated drugs:

Fasudil is being tested in this clinical trial to see if it is safe and well-tolerated by patients with Parkinson’s Disease. The trial aims to understand how this medication might help with symptoms of the disease. Fasudil is taken orally in a solution form over a period of 22 days.

Investigated diseases:

Parkinson's disease

Idiopathic Parkinson’s Disease – This is a progressive neurological disorder characterized by the gradual loss of dopamine-producing neurons in the brain. It primarily affects movement, leading to symptoms such as tremors, stiffness, slowness of movement, and balance problems. As the disease progresses, individuals may experience difficulties with walking and talking, as well as non-motor symptoms like sleep disturbances, mood changes, and cognitive impairment. The exact cause of the neuron loss is unknown, which is why it is termed “idiopathic.” Over time, the symptoms can become more pronounced, affecting daily activities and quality of life.

Trial ID:

2024-517413-33-00

Protocol code:

ROCK-PD-0000-LIN-007

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of Fasudil Hydrochloride for Patients with Parkinson’s Disease

What is this study about?

Who Can Join the Study?

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