This study is looking at Parkinson’s Disease that has been diagnosed recently, within the past two years. Parkinson’s Disease is a condition that affects the brain and leads to problems with movement, including shaking, stiffness, and difficulty with balance and coordination. The study will test a medication called BHV-8000, which is given as a tablet that releases the medicine slowly over time. Some people in the study will receive BHV-8000 while others will receive a placebo. The medication works by blocking certain proteins in the brain that may be involved in the disease process.
The purpose of the study is to find out if BHV-8000 can slow down the worsening of symptoms in people with early Parkinson’s Disease. The study will measure this by looking at how long it takes for symptoms to get worse based on a rating scale that asks about daily activities. The study will also use a special type of brain scan called DaT-SPECT, which uses a substance called ioflupane that is injected into a vein. This scan helps doctors see the activity of certain brain cells that produce a chemical called dopamine, which is important for movement. When these cells are not working properly, it suggests the disease is progressing.
People in the study will take the study medication or placebo for up to 48 weeks. During this time, doctors will regularly check how the disease is affecting movement and daily activities using different rating scales. They will also monitor safety by checking for any unwanted effects and doing laboratory tests. The study will compare two different doses of BHV-8000 to placebo to see which dose works better and is safe for people with early Parkinson’s Disease.
1Initial assessment and baseline measurements
At the beginning of the study, your current health status will be assessed and recorded as the starting point for comparison.
A DaT-SPECT scan will be performed. This is a specialized imaging test that uses a small amount of radioactive material called ioflupane (123I), which will be given through a vein in your arm. This scan helps to visualize the dopamine-producing cells in your brain.
Your movement abilities and daily functioning will be evaluated using the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale, which includes questions about your daily activities and a physical examination of your movements.
Your overall illness severity will be assessed using the Clinical Global Impression of Severity scale, where a clinician will rate how your condition affects you.
Blood samples will be collected for laboratory tests to check your overall health.
2Beginning of treatment phase
You will be assigned to receive either BHV-8000 or placebo. A placebo is an inactive substance that looks identical to the actual medication but contains no active ingredient.
If you receive BHV-8000, you will be given one of two dose levels. The medication is a prolonged-release tablet, which means it releases the active substance slowly over time.
You will take the assigned medication by mouth as directed.
Neither you nor your doctor will know whether you are receiving the actual medication or placebo during the study.
3Ongoing treatment and monitoring
You will continue taking your assigned medication throughout the study period.
Regular visits will be scheduled to monitor your condition and assess how the treatment is affecting you.
During these visits, your movement abilities and daily functioning will be evaluated repeatedly using the same assessment tools as at the beginning.
Your doctor will continue to rate the severity of your illness at each visit.
Blood samples will be collected periodically to monitor for any changes in laboratory values that might indicate safety concerns.
Any side effects or health problems that occur will be recorded and assessed for severity.
4Final assessment at week 48
After 48 weeks of treatment, a complete final assessment will be performed.
A second DaT-SPECT scan will be conducted using the same radioactive material given through a vein. This scan will be compared to your initial scan to measure any changes in dopamine-producing cells.
Your movement abilities and daily functioning will be evaluated again using the same rating scales.
Your overall illness severity will be assessed by the clinician.
The Parkinson’s Disease Composite Score-Function will be calculated. This is a combined score that includes information about your daily activities and quality of life.
Final blood samples will be collected for laboratory testing.
All side effects and health problems that occurred during the study will be reviewed.
Who Can Join the Study?
You must be between 40 and 85 years old at the time you agree to join the study
You must meet the criteria for “Probable PD”, which means your doctor has determined you likely have Parkinson’s Disease based on specific medical standards set by the Movement Disorder Society
You must have been diagnosed by a doctor with idiopathic PD, which means Parkinson’s Disease that occurs without a known cause, and this diagnosis must have been made within 2 years before your first study visit
Both men and women can participate in this study
Who Cannot Join the Study?
The study does not provide specific exclusion criteria in the available information, which means the detailed reasons why someone cannot participate have not been listed in the source data.
Generally, clinical trials may exclude patients based on other health conditions, use of certain medications, or other factors that could affect the study results or patient safety, but these specific details are not available for this particular trial.
If you are interested in participating, a doctor conducting the study would need to review your complete medical history to determine if you meet all requirements.
BHV-8000 is an investigational medication being studied for the treatment of early Parkinson’s disease. In this trial, it is being tested to see if it can help slow down the worsening of symptoms related to daily activities and movement difficulties that people with Parkinson’s disease experience. The medication is compared against a placebo to determine if it is effective in delaying the progression of the disease.
Early Parkinson’s Disease – Early Parkinson’s Disease is the initial stage of a progressive neurological disorder that affects movement control. The condition occurs when nerve cells in the brain that produce dopamine, a chemical messenger important for coordinating movement, begin to deteriorate or die. People with this condition may experience mild tremors, slight stiffness in limbs, changes in posture, and reduced facial expressions. As the disease progresses, motor symptoms gradually worsen, affecting the ability to perform daily activities such as writing, buttoning clothes, or walking. The early stage is characterized by symptoms that are often subtle and may appear on one side of the body before affecting both sides. Over time, the reduction in dopamine-producing cells leads to increasing difficulties with movement coordination and motor function.
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