Study of apomorphine and rifaximin for Parkinson’s disease patients with reduced levodopa effectiveness

2 1 1

What is this study about?

This clinical trial focuses on Parkinson’s disease, a progressive nervous system disorder that affects movement. The study aims to improve symptom management in patients whose bodies break down levodopa (a standard medication for Parkinson’s disease) too quickly. The research will test different treatment approaches using several medications: apomorphine (a medication that directly stimulates dopamine receptors in the brain), rifaximin (an antibiotic), and a placebo.

The study will compare how well these different treatments work in patients who have difficulty with their regular Parkinson’s medication. Participants will receive either Dacepton (which contains apomorphine) as an injection under the skin, Xifaxan (which contains rifaximin) as tablets taken by mouth, or placebo capsules. Some participants will also continue taking their regular Madopar medication, which contains a combination of levodopa and benserazide.

During the study, patients will take different combinations of these medications. Domperidone tablets may be given to some participants to prevent possible side effects. The treatment period will last for several weeks, during which the effectiveness of these different approaches will be evaluated to determine which method works best for managing Parkinson’s disease symptoms in patients who have this specific problem with levodopa treatment.

1 Initial treatment phase

You will receive levodopa (Madopar 125 mg) in combination with domperidone (10 mg tablets) for symptom management

The medication will be taken by mouth according to your prescribed schedule

Your response to the treatment will be measured using specific movement assessments

2 Treatment with rifaximin or placebo

You will be given either rifaximin (Xifaxan 550 mg film-coated tablets) or placebo capsules

The tablets are to be taken by mouth

Neither you nor your doctor will know whether you are receiving the active medication or placebo

3 Apomorphine treatment phase

You will receive apomorphine (Dacepton 10 mg/ml) through subcutaneous injection

This medication is delivered under the skin using a special cartridge system

Your movement symptoms will be assessed to measure the treatment response

4 Monitoring and assessment

Your condition will be evaluated using several rating scales that measure movement ability

You will need to temporarily stop taking your regular Parkinson’s medication for up to 12 hours on multiple occasions

Biological samples will be collected throughout the study

The total duration of the study is from December 2024 to February 2026

Who Can Join the Study?

  • Must be at least 25 years old
  • Can be either male or female
  • Must be able to read and understand Dutch language
  • Must sign an informed consent form that has been approved by the ethics board
  • Must be willing and able to:
    – Follow all study requirements
    – Stop taking Parkinson’s medication for up to 12 hours at multiple times
    – Provide biological samples when required
  • Must have Parkinson’s disease diagnosed by a neurologist according to standard clinical criteria
  • Must have documented levodopa resistance (reduced response to standard Parkinson’s medication)
  • Must have either:
    – Increased levels of AADC enzyme (a protein that breaks down levodopa) in blood, or
    – Increased levels of TDC enzyme (another protein that breaks down levodopa) in stool samples

Who Cannot Join the Study?

  • Current use of antibiotics or having taken them within the last 30 days
  • Known allergic reactions to apomorphine or rifaximin
  • History of severe heart disease or recent heart attack (within last 6 months)
  • Severe liver problems or abnormal liver function tests
  • Severe kidney disease requiring dialysis
  • Presence of dementia (significant memory and thinking problems)
  • History of alcohol or drug abuse within the past year
  • Pregnant women or women planning pregnancy
  • Breastfeeding mothers
  • Current participation in other clinical trials
  • Having deep brain stimulation (a surgical treatment where electrodes are placed in the brain)
  • Severe depression or other major psychiatric disorders
  • Unable to follow study instructions or attend regular visits
  • History of frequent fainting episodes
  • Severe digestive system disorders

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Stichting Radboud University Medical Center Nijmegen The Netherlands

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

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.12.2024

Trial locations

Levodopa is a medication that helps manage Parkinson’s disease symptoms by converting into dopamine in the brain. It is the most common treatment for Parkinson’s disease, helping to control tremors, stiffness, and movement difficulties.

Apomorphine is a medication that directly stimulates dopamine receptors in the brain, bypassing the need for conversion by enzymes. It can be helpful for Parkinson’s disease patients who don’t respond well to levodopa treatment.

Rifaximin is an antibiotic medication that works in the digestive system. In this trial, it is being studied for its potential to reduce bacteria that may interfere with Parkinson’s disease medications by producing certain enzymes.

Investigated diseases:

Parkinson’s disease – A progressive neurological disorder that affects movement and motor control. The condition develops when nerve cells in a specific part of the brain begin to break down and die, leading to decreased production of dopamine, a crucial chemical messenger. The disease typically causes tremors, particularly in the hands, arms, legs, and face, as well as stiffness or slowing of movement. People with Parkinson’s disease may also experience changes in their balance, coordination, and speech patterns. The symptoms usually start gradually and worsen over time, with one side of the body often being affected first before spreading to both sides.

Trial ID:
2024-510629-24-00
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A Study Testing SUL-238 in Patients with Early, Untreated Parkinson’s Disease to Assess Effects on Brain Energy Metabolism

    Recruiting

    2 1
    Investigated diseases:
    The Netherlands
  • Study of IPX203 compared to levodopa/carbidopa in patients with advanced Parkinson’s disease and motor fluctuations

    Recruiting

    3 1 1 1
    Italy Poland Spain