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Study on Amantadine for Reducing Motor Fluctuations in Advanced Parkinson's Disease Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called amantadine on people with advanced Parkinson's disease. Parkinson's disease is a condition that affects the brain and leads to symptoms like shaking, stiffness, and difficulty with balance and coordination. As the disease progresses, patients often experience "motor fluctuations," which means their ability to move can vary throughout the day. The study will use a medication called MANTADIX 100 mg, which contains amantadine hydrochloride, and compare it to a placebo. The purpose of the study is to see if amantadine can help reduce these motor fluctuations in patients with advanced Parkinson's disease.

Participants in the study will be randomly assigned to receive either the amantadine capsules or a placebo. The study will last for three months, during which time participants will take the medication daily. Throughout the study, participants will be monitored to see how their motor fluctuations change over time. This will help researchers understand if amantadine is effective in managing these symptoms. The study is designed to be "double-blinded," meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo, to ensure unbiased results.

By the end of the study, researchers aim to gather information on how well amantadine works in reducing motor fluctuations in people with advanced Parkinson's disease. This information could be valuable in improving treatment options for those living with this condition. Participants will also be monitored for any side effects to ensure the safety of the medication. The study will provide insights into whether amantadine can be a beneficial add-on therapy for managing symptoms of advanced Parkinson's disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of advanced Parkinson's disease for at least three years and signs of motor fluctuations.
Participants must be between 30 and 80 years old and have stable anti-Parkinson medication for at least four weeks before starting the trial.
Step 2
Initial assessment
An initial assessment is conducted to establish a baseline for motor fluctuations using Hauser diaries over three consecutive days.
Participants are required to complete these diaries to record their motor fluctuations, known as Off-time.
Step 3
Treatment phase
Participants are randomly assigned to receive either MANTADIX 100 mg capsules or a placebo. The treatment is administered orally.
The treatment duration is three months, during which participants continue their regular anti-Parkinson medication.
Step 4
Ongoing monitoring
Throughout the treatment phase, participants are monitored for changes in motor fluctuations and any side effects.
Participants may be asked to wear a device called a PDMonitor to assess their condition during the first and second weeks of the trial.
Step 5
Final assessment
At the end of the three-month treatment period, a final assessment is conducted to evaluate changes in motor fluctuations using the Hauser diaries.
Additional evaluations may include questionnaires and scales to assess other symptoms and overall satisfaction with the treatment.
Step 6
Completion of the study
Upon completion of the study, participants' data is analyzed to determine the effectiveness and safety of the treatment.
The study aims to understand the impact of amantadine on motor fluctuations in advanced Parkinson's disease.

Who can join the trial?

9 criteria

Must have been diagnosed with Parkinson's disease for at least 3 years, following specific guidelines.
Should be in the HY 2-3 stage when taking medication. This refers to a scale that measures the severity of Parkinson's symptoms, with 2-3 indicating moderate symptoms.
Age should be between 30 and 80 years.
Must have experienced motor fluctuations for at least 4 weeks before the study. This means having periods when movement is difficult, even with medication, for at least 2 hours a day, including trouble moving in the morning.
Should not have taken amantadine before. Amantadine is a medication used to help with movement problems in Parkinson's disease.
Must be part of a social security scheme, which means having access to health benefits or insurance.
Must have signed a form agreeing to participate in the study after understanding what it involves.
Should be able to fill out Hauser diaries, which are records of daily symptoms and medication effects.
Any other medications for Parkinson's should have been stable for at least 4 weeks before starting the study.

Who cannot join the trial?

4 criteria

Patients who do not have advanced Parkinson's disease cannot participate. Advanced Parkinson's disease is a stage of the disease where symptoms are more severe and may include significant movement problems.
Patients who are not experiencing motor fluctuations cannot participate. Motor fluctuations refer to changes in the ability to move, often seen as periods of good movement and periods of difficulty moving.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
Centre Hospitalier Et Universitaire De Limoges
Verified
Limoges, France
Hospices Civils De Lyon
Responsive
Lyon, France

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Investigated drugs

Amantadine is a medication used in this trial as an additional treatment for patients with advanced Parkinson's disease. It is being studied to see if it can help reduce motor fluctuations, which are periods when the usual Parkinson's medications are not working well, leading to increased symptoms. The trial aims to determine if adding amantadine can improve these "Off-time" periods over a three-month treatment period.

Amantadine Hydrochloride

What is already known about the treatment

Amantadine – Amantadine is administered orally in the form of capsules or tablets. It is currently being studied as an add-on therapy for advanced Parkinson's disease, specifically to address motor fluctuations. The medication works by influencing the release and reuptake of dopamine, a key neurotransmitter involved in movement control. It is classified as an antiviral and antiparkinsonian agent.

Investigated diseases

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. As the disease advances, individuals may experience a decrease in spontaneous movements, a shuffling walk, and difficulty with speech. The progression of symptoms can vary widely among individuals, with some experiencing rapid changes and others having a slower progression. Over time, non-motor symptoms such as sleep disturbances, mood changes, and cognitive impairment may also develop. The disease primarily affects older adults, but early-onset cases can occur.