Study on the Long-Term Safety of Tavapadon 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 medication called Tavapadon, which is taken as a tablet. Tavapadon is an investigational drug, meaning it is still being studied and is not yet approved for general use. The purpose of this study is to evaluate the long-term safety and tolerability of Tavapadon for people diagnosed with Parkinson’s disease.

Participants in the trial will take Tavapadon orally, which means by mouth, for a period of up to 58 weeks. During this time, researchers will monitor participants to see how they respond to the medication and to check for any side effects. The study will also look at how Tavapadon affects the symptoms of Parkinson’s disease over the long term. This includes observing changes in movement and daily activities, as well as any adjustments in the use of other medications like L-Dopa, which is commonly used to manage Parkinson’s symptoms.

The trial will involve regular check-ups, including physical and neurological examinations, to ensure participants’ safety and to gather data on the effects of Tavapadon. Researchers will also collect information through various assessments and tests to understand how the medication impacts speech and facial expressions, which can be affected by Parkinson’s disease. The study aims to provide valuable insights into the potential benefits and risks of using Tavapadon for managing Parkinson’s disease over an extended period.

1 joining the trial

Upon completion of a previous 27-week double-blind treatment period in a related trial, entry into this trial must occur within 72 hours.

Participants must continue using levodopa/carbidopa or levodopa/benserazide if applicable.

2 medication administration

The investigational product, tavapadon, is administered in tablet form.

The route of administration is oral use.

3 trial duration

The trial is designed to last for 58 weeks.

The primary objective is to evaluate the safety and tolerability of long-term administration of tavapadon.

4 safety and tolerability assessments

Regular assessments will be conducted to monitor the nature, frequency, and timing of any adverse effects.

Evaluations include clinical laboratory tests, vital signs, physical and neurological examinations, and ECGs.

5 symptom evaluation

The effects of tavapadon on Parkinson’s disease symptoms will be assessed through changes in specific scores and diaries.

Speech and facial expression characteristics may be analyzed using digital testing on a mobile device.

6 completion of trial

The trial is expected to conclude by December 12, 2025.

Participants will be monitored for any changes in medication usage and overall health status.

Who Can Join the Study?

  • Participants must have completed a previous 27-week treatment period in one of the specified trials and join this new trial within 72 hours after their last visit in the previous trial. If they are from a specific trial, they must continue using certain medications for Parkinson’s disease during the trial.
  • Men and women who can have children must agree to use effective birth control methods or choose not to have sexual activity during the trial and for 4 weeks after the last dose of the trial treatment.
  • Participants must be able to give their signed consent, which means they agree to follow the rules and requirements of the trial.
  • Participants must be able to understand the trial and follow the trial’s rules, including taking the right doses of medication, attending scheduled visits, and completing tests and other trial activities.
  • Participants must have shown they could follow the trial’s rules and take the trial medication properly in the previous trial.
  • Participants must agree not to take any Parkinson’s disease medications that are not allowed by the trial rules during their participation in the trial.

Who Cannot Join the Study?

  • Patients who have a different condition than Parkinson’s disease cannot participate.
  • Individuals who are not within the specified age range for the study are excluded.
  • Participants who do not meet the gender requirements for the study are not eligible.
  • People who are considered part of a vulnerable population are excluded. This means individuals who might be at a higher risk of harm or exploitation.

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
Etg Neuroscience Sp. z o.o. Warsaw Poland
Centre Hospitalier Universitaire De Nimes Nimes France
St. Josef-Hospital Bochum Germany
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Milan Italy
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Policlinica Gipuzkoa S.A. Donostia / San Sebastian Spain
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz Poland
Neurohk s.r.o. Chocen Czechia
Specjalistyczne Gabinety Sp. z o.o. Cracow Poland
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Linden Sp. z o.o. sp.k. Cracow Poland
Hospital Universitario Hm Puerta Del Sur Mostoles Spain
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH Bad Homburg Germany
Fondazione Santa Lucia Rome Italy
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
Irccs San Raffaele Roma S.r.l. Rome Italy
Azienda Ospedaliera di Padova Padua Italy
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
Clintrial s.r.o. Prague Czechia
curiositas ad sanum Studien und Beratungs GmbH Haag in Obb Germany
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Di Pisa Pisa Italy
Pratia S.A. Skorzewo Poland
Hospices Civils De Lyon Lyon France
Vestra Clinics s.r.o. Rychnov Nad Kneznou Czechia
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
University Of Pecs Pecs Hungary
Hopital Beaujon Clichy France
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Sofia Bulgaria
Forbeli s.r.o. Prague Czechia
Aoty Cqpefgeo suqeqj Prague Czechia
Hfzogyid Udiyxqvwpwtdq Dx Lz Peerywph Madrid Spain
Mmnfauz Cdkyar Vzjw 1 Lajg Pleven Bulgaria
Nmjqjrayps Sxk z oyjj sepfo Katowice Poland
Ntjhpredacyj Zutpbe Okouve Zbqtygnxtf Wsvxoolythewgcxrymij Pexrvxmy Lglwaquj Stdznrxy Lbrq Shqfyvjpdfis Katowice Poland
Sqyohzarhrfwvoz Pnbteuyi Lkvcwmtc Do Splhobskw Oyyjvhq Katowice Poland
Cwfzfvy Mfdgffic Hnkp Ctbtpd Lublin Poland
Ahokknrpcm Pwwkdwar Hzmenbhj Db Mltxapugn Marseille France
Azegeht Osyarmuyrbo Ueogryyxzhzvk Cretehepzvww Dfuek Slcbnb E Djyne Smyibrh Db Ttgkvt Turin Italy
Uwuvimipzgjpxnxarkzhc Multvrzj Acz Munster Germany
Cfqv Dn Ncdlq Vandoeuvre Les Nancy France
Kneiloxe dsf Uhyonmgnfxvy Mukxldqh Ajr Munich Germany
Mkmfdtiw Mpzfvqg Aloqwdb Pleven Bulgaria
Hzqpiula Dx Lf Swrvo Ctux I Snwk Pfe Barcelona Spain
Howpnfba Vgby dzhfgbwn Barcelona Spain
Axvaktqxc Fdmkchfzahgc Sgxvddlut Gnfp Stadtroda Germany
Hwkfjhgx Uxzhmpqnewmbtt Swuqoiqhjn &yfrqxu Hstpjev db Hotaerqccrf STRASBOURG, Alsace France
Ptjjzo fhc Nxyjwoizym uma Pmafoxpwwod Dih Ctknvglen Oqrljnxd Gera Germany

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
23.06.2021
Czechia Czechia
Not recruiting
23.06.2021
France France
Not recruiting
23.06.2021
Germany Germany
Not recruiting
23.06.2021
Hungary Hungary
Not recruiting
23.06.2021
Italy Italy
Not recruiting
23.06.2021
Poland Poland
Not recruiting
23.06.2021
Spain Spain
Not recruiting
23.06.2021

Trial locations

Investigated drugs:

Tavapadon is a medication being studied for its potential use in treating Parkinson’s Disease. The trial aims to assess how safe and well-tolerated this medication is when taken over a long period. Tavapadon works by targeting specific receptors in the brain that are involved in movement control, which may help alleviate symptoms of Parkinson’s Disease.

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 progresses, individuals may experience slowness of movement and changes in speech and writing. The symptoms are due to the loss of dopamine-producing neurons in the brain. Over time, non-motor symptoms such as sleep disturbances, mood changes, and cognitive impairment may also develop. The progression of symptoms varies from person to person.

Trial ID:
2024-512123-37-00
Protocol code:
CVL-751-PD-004
NCT ID:
NCT04760769
Trial Phase:
Therapeutic confirmatory (Phase III)

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