Study on the Effects of Prasinezumab in Patients with Early Parkinson’s Disease

2 1 1

What is this study about?

This clinical trial is focused on studying Parkinson’s disease, specifically in its early stages. The treatment being tested is called prasinezumab, which is also known by its code name RO7046015. Prasinezumab is a type of medication that is given through an intravenous infusion, meaning it is administered directly into the bloodstream through a vein. The purpose of this study is to evaluate how effective prasinezumab is in treating early Parkinson’s disease over a period of 52 weeks.

Participants in the study will receive either prasinezumab or a placebo. The study is designed to be double-blind, which means neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The study will last for a total of 52 weeks, with an additional extension period where all participants will receive the treatment. During the study, participants will be monitored for changes in their symptoms and overall health.

Parkinson’s disease is a condition that affects movement, causing symptoms such as tremors, stiffness, and difficulty with balance and coordination. The study aims to see if prasinezumab can help improve these symptoms in people who are in the early stages of the disease. Participants will be assessed using various scales and tests to measure changes in their condition. The study will also monitor for any side effects or adverse reactions to the treatment. This research is important for understanding how prasinezumab might benefit people with early Parkinson’s disease and potentially improve their quality of life.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, such as a diagnosis of early Parkinson’s disease for two years or less and a stable condition without the need for dopaminergic medication within the next 52 weeks.

2 initial assessment

An initial assessment is conducted to establish a baseline. This includes a brain scan and evaluation of symptoms using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).

3 treatment phase

Participants receive either the study medication, prasinezumab (RO7046015), or a placebo. The medication is administered as an intravenous infusion.

The treatment is given regularly over a period of 52 weeks.

4 monitoring and assessments

Throughout the 52-week period, regular monitoring and assessments are conducted to evaluate changes in symptoms and overall health.

Assessments include changes in the MDS-UPDRS score, cognitive function, and daily living activities.

5 end of initial study phase

At the end of the 52-week period, a final assessment is conducted to measure the efficacy of the treatment compared to the placebo.

The primary focus is on the change in the MDS-UPDRS total score from the baseline.

6 extension phase

Participants have the option to continue in a 6-year extension phase where all receive the treatment.

This phase aims to gather long-term data on the treatment’s effects.

Who Can Join the Study?

  • The patient must have a brain scan called DaT-SPECT that matches the pattern seen in Parkinson’s disease.
  • The patient’s condition should not need medication that increases dopamine levels, and it should not be expected to need such treatment within 52 weeks from the start of the study.
  • If the patient is currently taking medication for Parkinson’s disease, they must be on a stable dose of a type of medication called MAO-B inhibitor (such as rasagiline or selegiline) for at least 90 days before starting the study, and this dose should not change during the study period.
  • The patient must have idiopathic Parkinson’s disease, which means Parkinson’s disease with no known cause, showing slowness of movement (bradykinesia) and at least one other main symptom like shaking at rest (resting tremor) or muscle stiffness (rigidity), without any other known or suspected cause.
  • The patient must have been diagnosed with Parkinson’s disease for 2 years or less at the time of screening.
  • The patient must be in Hoehn and Yahr Stage I or II, which are early stages of Parkinson’s disease.
  • Both male and female patients can participate.

Who Cannot Join the Study?

  • Patients who have a different type of Parkinson’s disease other than Early Idiopathic Parkinson’s disease cannot participate. This means the study is only for those with a specific early form of Parkinson’s disease.
  • Patients who are in a more advanced stage of Parkinson’s disease than H&Y Stages I-II are not eligible. H&Y stages refer to the Hoehn and Yahr scale, which measures the severity of Parkinson’s disease.
  • Patients who are taking medications other than monoamine oxidase-B (MAO-B) inhibitors for Parkinson’s disease are excluded. MAO-B inhibitors are a type of medication that helps manage symptoms of Parkinson’s disease.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible for this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaet Leipzig Leipzig Germany
Medizinische Universitaet Innsbruck Innsbruck Austria
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France
Oncopole Claudius Regaud Toulouse France
Aix Marseille University Marseille France

Other Sites

Site Name City Country Status
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Centre Hospitalier Universitaire De Poitiers Poitiers France
CHU Gabriel-Montpied Clermont Ferrand France
Pellegrin Hospital Bordeaux France
Policlinica Gipuzkoa S.A. Donostia / San Sebastian Spain
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA Kassel Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Hrdoicdp Ds Lr Sqzhx Crgn I Snof Pai Barcelona Spain
Hpgcwwqd Uyzqeiomtiovw Dj Li Pzrhmcjy Madrid Spain
Uwfivclxmvlspnmwamdfm Diajpmrqmnd Adh Duesseldorf Germany
Haehxowf Vqox dscoqjmu Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
15.12.2017
France France
Recruiting
15.12.2017
Germany Germany
Recruiting
15.12.2017
Spain Spain
Recruiting
15.12.2017

Trial locations

Investigated drugs:

RO7046015/Prasinezumab (PRX002) is an investigational medication being studied for its potential to treat early Parkinson’s disease. It is administered intravenously and is designed to target and bind to a specific protein associated with Parkinson’s disease. The goal of this medication is to slow down the progression of the disease by reducing the harmful effects of this protein in the brain. This study aims to evaluate how effective this medication is in improving symptoms of Parkinson’s disease over a 52-week period.

Investigated diseases:

Parkinson’s Disease – Parkinson’s disease is a progressive neurological disorder that affects movement. It typically begins with subtle symptoms such as a slight tremor in one hand, but over time, it can lead to more pronounced tremors, stiffness, and slowing of movement. As the disease progresses, individuals may experience difficulties with balance and coordination. Non-motor symptoms, such as changes in mood, sleep disturbances, and cognitive impairment, can also occur. The progression of symptoms varies from person to person, and the rate of progression can differ widely.

Trial ID:
2023-504472-24-00
Protocol code:
BP39529
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
    Investigated diseases:
    Italy Poland Spain