Study on the Effectiveness and Safety of BIIB122 for Patients with Parkinson’s Disease

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What is this study about?

This clinical trial is focused on studying Parkinson’s Disease, a condition that affects movement and can cause symptoms like tremors, stiffness, and difficulty with balance and coordination. The trial is testing a new treatment called BIIB122, which is a tablet taken orally. The purpose of the study is to evaluate how effective and safe BIIB122 is compared to a placebo, which looks like the real medication but does not contain any active ingredients.

Participants in the study will be randomly assigned to receive either BIIB122 or the placebo. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will take place over a period of time, during which participants will be monitored for any changes in their symptoms and any side effects they might experience.

The main goal is to see if BIIB122 can slow down the worsening of symptoms associated with Parkinson’s Disease. Researchers will use a specific scale called the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) to measure changes in symptoms. They will also track any adverse events or serious adverse events that occur during the study. The study aims to provide valuable information about the potential benefits and risks of BIIB122 for people living with Parkinson’s Disease.

1 randomization and initial assessment

Upon joining the study, participants are randomly assigned to receive either the BIIB122 medication or a matching placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

An initial assessment is conducted to establish baseline measurements. This includes evaluating the participant’s condition using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and other relevant scales.

2 medication administration

Participants take the assigned medication orally in the form of a tablet. The dosage for BIIB122 is 225 mg.

The medication is taken according to the study’s schedule, which is determined by the research team. The duration of administration is throughout the treatment period specified in the study protocol.

3 ongoing assessments

Regular assessments are conducted to monitor the participant’s condition and any changes in symptoms. These assessments include repeated evaluations using the MDS-UPDRS and other scales.

The study aims to track the time to confirmed worsening in the MDS-UPDRS Parts II and III combined score, as well as other secondary endpoints such as the incidence of adverse events.

4 completion of treatment period

At the end of the treatment period, a final assessment is conducted to evaluate the overall efficacy and safety of the treatment.

Participants’ data is analyzed to determine the impact of BIIB122 compared to the placebo, focusing on the primary and secondary endpoints outlined in the study.

Who Can Join the Study?

  • You must have a clinical diagnosis of Parkinson’s Disease that meets specific criteria within 2 years of the screening visit. You should have been at least 30 years old when diagnosed.
  • Your condition should be at stages 1 to 2 on the Modified Hoehn and Yahr scale when not taking medication. This scale measures the severity of Parkinson’s Disease.
  • Your combined score on parts II and III of the MDS-UPDRS (a scale used to measure Parkinson’s symptoms) should be 40 or less when not taking medication.
  • A genetic test must show that you do not have certain specific changes (called variants) in a gene known as LRRK2. These changes are linked to Parkinson’s Disease. The test must be done by a recognized lab and include all the specific variants that would exclude you from the study.
  • Other criteria defined in the study protocol may also apply.

Who Cannot Join the Study?

  • Patients who have a different condition than Parkinson’s Disease cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet other specific criteria set by the study, which are not listed here, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Novo-Med Zielinski I Wspolnicy Sp. j. Katowice Poland
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Katholisches Klinikum Bochum gGmbH Bochum Germany
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Policlinica Gipuzkoa S.A. Donostia / San Sebastian Spain
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA Kassel Germany
Brain Research Center Amsterdam B.V. Amsterdam The Netherlands
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz Poland
Brain Research Center Zwolle B.V. Zwolle The Netherlands
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Ospedaliera di Padova Padua Italy
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario De Cruces Barakaldo Spain
Irccs San Raffaele Roma S.r.l. Rome Italy
Universita’ Di Pisa Pisa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Istituto Neurologico Mediterraneo Neuromed S.p.A. Pozzilli Italy
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Neuroprotect Sp. z o.o. Warsaw Poland
Htghnywl Uzjljlkpmsyhp Dm Lp Pyrfddqj Madrid Spain
Hyhkqxkd Uwqsoyadizqwk Mzopdru Dq Vftlakqmlu Santander Spain
Mq Caxyrb Ppfdq Sax z odwl Warsaw Poland
Atmhakinqr Phkxbapz Hleydhxb Dv Mpybtvrdh Marseille France
Unpmszhyaeeqvhtushsne Dvvcavlasog Ane Duesseldorf Germany
Strdhbfkd Rvsujgt Umgqukikwv Mgjpozw Chwijw Nijmegen The Netherlands
Kixvsdbo die Uukkmprcejit Mjyfaxfu Agy Munich Germany
Ukuemvmwmmscrvgbsoyvo Wpqptaqgp Ako Wuerzburg Germany
Hnoompsk Dp Le Swrss Ckgn I Sfaq Pze Barcelona Spain
Hbynrqbx Vlms dztnkvqe Barcelona Spain
Ijrtdnpe Zfbtfdw Dm Beudbqttmcnnzqutz Oświęcim Poland
Hkgrvkul Umburbhochtaa di A Cjsltn A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
11.04.2022
France France
Not recruiting
11.04.2022
Germany Germany
Not recruiting
11.04.2022
Italy Italy
Not recruiting
11.04.2022
Poland Poland
Not recruiting
11.04.2022
Spain Spain
Not recruiting
11.04.2022
The Netherlands The Netherlands
Not recruiting
11.04.2022

Trial locations

BIIB122 is a medication being studied for its effectiveness and safety in treating Parkinson’s Disease. The trial aims to determine how well this medication works in managing the symptoms of the disease compared to a placebo.

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. The disease progresses gradually, often starting with a barely noticeable tremor in just one hand. As it advances, individuals may experience slowness of movement, muscle rigidity, and impaired posture. Non-motor symptoms such as sleep disturbances, mood changes, and cognitive impairment can also occur. The exact cause of Parkinson’s Disease is unknown, but it involves the loss of nerve cells in the brain that produce dopamine.

Trial ID:
2023-505645-12-00
Protocol code:
283PD201
NCT ID:
NCT05348785
Trial Phase:
Therapeutic exploratory (Phase II)

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