Advanced Parkinson DiseaseELEGANCENCT05043103
Long-Term Observational Study on Effectiveness and Safety of Lecigon in Patients With Advanced Parkinson's Disease
An observational study of Advanced Parkinson Disease, run by Britannia Pharmaceuticals Ltd. at 57 sites in 14 countries.
Trial summary
This observational study is designed to collect data on the use of the drug Lecigon® in daily clinical practice. The study is organised and funded by a pharmaceutical company called Britannia Pharmaceuticals Ltd (Britannia). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Parkinson Disease
- What is being tested?
- Lecigon® based on European Medicines Agency (EMA) SmPC
- How many people
- 312 participants
- Where
- 57 sitesin 14 countries
- Study dates
- 6 Jul 2021to 7 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Treating physician's normal patient pool
Who may be able to join
- Adult Patients (18 years old and over) with Advanced Parkinson Disease already under treatment with Lecigon® (for up to 3 months before giving informed consent) in accordance with the Summary of Product Characteristics (SmPC)
- Patients or legal representative must have signed informed consent to participate in the study
- Patients are not taking part in another clinical (interventional) study at the same time
Who cannot join
- Patients with contraindications as defined in the current version of the SmPC for Lecigon®
- Patients who will not be seen again for their follow up care at the investigator's site after commencement of Lecigon® therapy
- Patients with pump placement or pump use issues, e.g. patients with acute severe illness, patients unable to perform pump therapy, and in case of lacking compliance due to severe dementia, agitation or alcohol abuse
Trial locations and contacts
57 sites in 14 countries.
57 sites in 14 countries
Germany14 sites
Segeberger Kliniken GmbH Neurologisches Zentrum
Bad Segeberg, 23795
Kliniken Beelitz GmbH Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson
Beelitz-Heilstätten, 14547
Charité - Universitätsmedizin Berlin
Berlin, 10117
Uniklinik Köln
Cologne
Krankenhaus Lindenbrunn
Coppenbrügge, 31863
Klinik für Neurologie - Universitätsklinikum Essen
Essen, 45147
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
Freiburg im Breisgau, 79106
Zentrum für Seltene Erkrankungen Göttingen
Göttingen, 37075
Universitätsklinikum Giessen und Marburg
Marburg, 35043
Evangelisches Krankenhaus Oldenburg
Oldenburg, 26122
Klinikum Osnabrück GmbH Klinik für Neurologie
Osnabrück, 49076
Universitätsklinikum Tübingen
Tübingen, 72076
RKU - Universitäts und Rehabilitationskliniken Ulm gGmbH
Ulm, 89081
Parkinson-Klinik Ortenau
Wolfach, 77709
Romania10 sites
Emergency Hospital Brasov, Spitalul Clinic Județean de Urgență Brașov
Brasov, 500326
Spitalul Universitar de Urgență Elias
Bucharest, 011461
Colentina Hospital Bucharest
Bucharest, 020125
Bucharest University Emergency Hospital
Bucharest, 050098
Fundeni Clinical Institute
Bucharest
County Emergency Hospital Cluj-Napoca
Cluj-Napoca, 400347
County Clinical Emergency Hospital of Constanta
Constanța, 900591
Emergency County Hospital Targu Mures
Târgu Mureş, 540136
Timiş County Emergency Clinical Hospital- Neurology 1
Timișoara, 300723
Timiş County Emergency Clinical Hospital
Timișoara, 300723
Belgium5 sites
AZ Sint-Jan
Bruges, 8000
Antwerp University Hospital
Edegem, 2650
Ghent University Hospital
Ghent
University Hospital Liege
Liège
Centre Hospitalier de Wallonie picarde (Chwapi)
Tournai, 7500
Spain5 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Hospital de la Princesa
Madrid
Hospital Virgen del Rocio
Seville, 41013
Austria4 sites
Universitätsklinik für Neurologie, Medizinische Universität Graz
Graz, 8036
Abteilung für Neurologische Rehabilitation, Gailtal-Klinik
Hermagor, 9620
Universitätsklinik für Neurologie, Medizinische Universität Innsbruck
Innsbruck, 6020
Kepler Universitätsklinikum
Linz, 4020
Croatia4 sites
UHC Osijek, J. Klinici za neurologiju
Osijek, 31000
University Hospital Centre Rijeka (KBC Rijeka)
Rijeka
Klinička bolnica Dubrava
Zagreb, 10000
University Hospital Centre (KBC Zagreb)
Zagreb, 10000
Hungary3 sites
Semmelweis Egyetem Neurológiai Klinika Budapest
Budapest
Pécsi Tudományegyetem Klinikai Központ Szemészeti Klinika
Pécs, 7623
SZTE Szent-Györgyi Albert Klinikai Közpon
Szeged, 6725
Sweden3 sites
Sahlgrenska University Hospital
Gothenburg, 413 45
Skånes universitetssjukhus Lund
Lund
Uppsala university hospital
Uppsala, 751 85
Ireland2 sites
St. Vincent's University Hospital
Dublin, D04 T6F4
The Dublin Neurological Institute, Mater Hospital
Dublin, D07 R2WY
Slovenia2 sites
Department of Neurology, University Medical Centre
Ljubljana, 1000
Univerzitetni klinični center Maribor
Maribor, 2000
About this study
Official title: ELEGANCE - A Non-interventional Study on Long-term Effectiveness and Safety of Levodopa-Entacapone-Carbidopa Intestinal Gel (Lecigon®) in Patients With Advanced Parkinson's Disease in Routine Care
This observational study is designed to collect data on the use of the drug Lecigon® in daily clinical practice. The study is organised and funded by a pharmaceutical company called Britannia Pharmaceuticals Ltd (Britannia).
Lecigon® is prescribed by physicians in advanced Parkinson's disease when patients suffer from uncontrollable fluctuations in mobility, so-called motor fluctuations, which cannot be adjusted well with oral treatment, i.e. medication for swallowing.
In this study, data on the effect and possible side effects from everyday treatment with Lecigon® will be collected and scientifically evaluated. The study is intended to supplement the results of previous clinical studies with clinical data in routine medical care, collected from approximately 300 patients.
Read the detailed description
Study design:
Non-interventional study, primary data collection.
No visits or measurements will be made mandatory by the observational plan. The assignment of patients to Lecigon® not decided in advance by the study's observational plan but falls within current practice. Prescription of Lecigon® occurred before and independently of the decision to include the patient in the study.
The participating centres will offer participation in the ELEGANCE study to all patients who receive treatment with Lecigon® part of routine clinical practice. From patients, who switched to treatment with Lecigon® prior to signing of informed consent, baseline data will be collected retrospectively.
The planned non-interventional study aims to collect real-world data on the effectiveness and safety of Lecigon® as a therapy for advanced Parkinson´s Disease in routine care in Germany and Austria. The study will be expanded to additional European countries as soon as marketing authorisation in these countries and commercial stock will be available.
Primary Objectives:
- Long-term effectiveness of Lecigon®
- Long-term safety of Lecigon®
Secondary Objectives:
- Patient non-motor symptoms and quality of life
- Healthcare resource utilisation by patients
- Conditions
- Advanced Parkinson Disease
- Being tested
- Lecigon® based on European Medicines Agency (EMA) SmPC
- Keywords
- Parkinson´s Disease, Movement Disorders, Levodopa, Entacapone, Carbidopa Levodopa drug combination, Antiparkinson Agents, Anti-Dyskinesia-Agents, Dopamine Agents, Dopamine Agonists, Catechol-O-methyltransferase (COMT) inhibitor, Portable Pump, Gel, Quality of Life
- Medical subject headings
- Parkinson Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lecigon® based on European Medicines Agency (EMA) SmPCCombination product
There might be different brand names in other countries
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in OFF time from baseline up to 24 months, or treatment or study discontinuation
To assess the effectiveness of Lecigon® treatment on the change in OFF time (h/day) from baseline up to 24 months, or treatment or study discontinuation as measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale IV Scores (MDS-UPDRS IV- motor complications)
Measured: 24 months
Change in activities of daily living from baseline up to 24 months, or treatment or study discontinuation
To assess the effectiveness of Lecigon® treatment on the change in motor experiences of daily living from baseline up to 24 months, or treatment or study discontinuation as measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale II Scores (MDS-UPDRS II - motor experiences of daily living)
Measured: 24 months
Change in Daily Levodopa dose from baseline up to 24 months, or treatment or study discontinuation
To assess the effectiveness of Lecigon® treatment on the change in Daily Levodopa dose [mg/day] from baseline up to 24 months, or treatment or study discontinuation as measured by morning bolus, continuous flow, extra boli, oral doses
Measured: 24 months
Usage of other Anti-Parkinsonian medicinal products from baseline up to 24 months, or treatment or study discontinuation
To assess the effectiveness of Lecigon® treatment as measured by usage of other anti-Parkinsonian medicinal products (e.g. levodopa, dopamine agonists, Monoamine Oxidase (MAO)-B inhibitors, amantadine from baseline up to 24 months, or treatment or study discontinuation
Measured: 24 months
Usage of the Lecigon® pump from baseline up to 24 months, or treatment or study discontinuation
To assess the effectiveness of Lecigon® treatment use of programmed pump rate (2 or 3 rates) from baseline up to 24 months, or treatment or study discontinuation will be collected
Measured: 24 months
Change in Clinical Global Impression of Improvement (CGI-I) from baseline up to 24 months, or treatment or study discontinuation
To assess the effectiveness of Lecigon® treatment on the change in Clinical Global Impression of Improvement (CGI-I) from baseline up to 24 months, or treatment or study discontinuation as measured by Clinical Global Impression of Improvement Scale Score (CGI-I)
Measured: 24 months
Change in Patient Global Impression of Change from baseline up to 24 months, or treatment or study discontinuation
To assess the effectiveness of Lecigon® treatment on the change in Patient Global Impression of Change (PGI-C) from baseline up to 24 months, or treatment or study discontinuation as measured by Patient Global Impression of Change Scale Score (PGI-C)
Measured: 24 months
Satisfaction with treatment from baseline up to 24 months or treatment or study discontinuation
To assess the effectiveness with Lecigon®, satisfaction with treatment will be assessed in terms of pump size, weight, noise, handling and overall pump satisfaction from baseline up to 24 months or treatment or study discontinuation as measured by device satisfaction scale score between 0 (absolutely unsatisfied) to 10 (absolutely satisfied) for each item.
Measured: 24 months
Occurrence of AEs and SAEs from baseline up to 24 months or treatment or study discontinuation
To assess the long-term safety of Lecigon® treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) (including drug-related, device- and procedure-related Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs), AEs of special interest) from time of Informed consent to study completion for up to 24 months or treatment or study discontinuation will be collected
Measured: 24 months
Secondary outcomes (5)
Change in Non-Motor Symptoms from baseline up to 24 months, or treatment or study discontinuation
To assess the impact of Lecigon® treatment on the change in Non-Motor Symptoms from baseline up to 24 months, or treatment or study discontinuation as measured by Non-Motor Symptom Scale Scores (NMSS)
Measured: 24 months
Change in Sleep Quality from baseline up to 24 months, or treatment or study Discontinuation
To assess the impact of Lecigon® treatment on the change in sleep quality from baseline up to 24 months, or treatment or study discontinuation as measured by Parkinson's disease sleep Scale-2 Score (PDSS-2)
Measured: 24 months
Change in Activities of daily living from baseline up to 24 months, or treatment or study discontinuation
To assess the impact of Lecigon® treatment on the change in activities of daily living from baseline up to 24 months, or treatment or study discontinuation as measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale Ib Score (MDS-UPDRS Ib - non-motor experiences of daily living)
Measured: 24 months
Change in Quality of Life from baseline up to 24 months or treatment or study discontinuation
To assess the impact of Lecigon® treatment on the change in quality of life from baseline up to 24 months, or treatment or study discontinuation as measured by Parkinson's Disease Questionnaire total score (PDQ-8 or PDQ-39)
Measured: 24 months
Usage of Healthcare resources from baseline up to 24 months, or treatment or study discontinuation
To assess the impact of Lecigon® treatment on usage of Healthcare resources as measured by additional hospitalisation due to complications out of scope of nurse support team since the last visit
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start6 Jul 2021
- Primary completion7 Oct 2026 (estimated)
- Study completion7 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Britannia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043103
- Sponsor's protocol ID
- NIS-MA-2020-02
- Acronym
- ELEGANCE
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2021
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELEGANCE - A Non-interventional Study on Long-term Effectiveness and Safety of Levodopa-Entacapone-Carbidopa Intestinal Gel (Lecigon®) in Patients With Advanced Parkinson's Disease in Routine Care
- ClinicalTrials.gov ID
- NCT05043103
- Acronym / sponsor ID
- ELEGANCE / NIS-MA-2020-02
- Conditions
- Advanced Parkinson Disease
- Keywords
- Parkinson´s Disease, Movement Disorders, Levodopa, Entacapone, Carbidopa Levodopa drug combination, Antiparkinson Agents, Anti-Dyskinesia-Agents, Dopamine Agents
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Britannia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 7 Oct 2026 (estimated)
- Study completion
- 7 Oct 2026 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study is designed to collect data on the use of the drug Lecigon® in daily clinical practice. The study is organised and funded by a pharmaceutical company called Britannia Pharmaceuticals Ltd (Britannia).
Lecigon® is prescribed by physicians in advanced Parkinson's disease when patients suffer from uncontrollable fluctuations in mobility, so-called motor fluctuations, which cannot be adjusted well with oral treatment, i.e. medication for swallowing.
In this study, data on the effect and possible side effects from everyday treatment with Lecigon® will be collected and scientifically evaluated. The study is intended to supplement the results of previous clinical studies with clinical data in routine medical care, collected from approximately 300 patients.
Detailed description
Study design:
Non-interventional study, primary data collection.
No visits or measurements will be made mandatory by the observational plan. The assignment of patients to Lecigon® not decided in advance by the study's observational plan but falls within current practice. Prescription of Lecigon® occurred before and independently of the decision to include the patient in the study.
The participating centres will offer participation in the ELEGANCE study to all patients who receive treatment with Lecigon® part of routine clinical practice. From patients, who switched to treatment with Lecigon® prior to signing of informed consent, baseline data will be collected retrospectively.
The planned non-interventional study aims to collect real-world data on the effectiveness and safety of Lecigon® as a therapy for advanced Parkinson´s Disease in routine care in Germany and Austria. The study will be expanded to additional European countries as soon as marketing authorisation in these countries and commercial stock will be available.
Primary Objectives:
- Long-term effectiveness of Lecigon®
- Long-term safety of Lecigon®
Secondary Objectives:
- Patient non-motor symptoms and quality of life
- Healthcare resource utilisation by patients
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treating physician's normal patient pool
Key inclusion criteria (3 listed)
- Adult Patients (18 years old and over) with Advanced Parkinson Disease already under treatment with Lecigon® (for up to 3 months before giving informed consent) in accordance with the Summary of Product Characteristics (SmPC)
- Patients or legal representative must have signed informed consent to participate in the study
- Patients are not taking part in another clinical (interventional) study at the same time
Key exclusion criteria (3 listed)
- Patients with contraindications as defined in the current version of the SmPC for Lecigon®
- Patients who will not be seen again for their follow up care at the investigator's site after commencement of Lecigon® therapy
- Patients with pump placement or pump use issues, e.g. patients with acute severe illness, patients unable to perform pump therapy, and in case of lacking compliance due to severe dementia, agitation or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lecigon® based on European Medicines Agency (EMA) SmPCThere might be different brand names in other countries | Combination product | – |
Primary outcome
Change in OFF time from baseline up to 24 months, or treatment or study discontinuation
Time frame: 24 months
To assess the effectiveness of Lecigon® treatment on the change in OFF time (h/day) from baseline up to 24 months, or treatment or study discontinuation as measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale IV Scores (MDS-UPDRS IV- motor complications)
Change in activities of daily living from baseline up to 24 months, or treatment or study discontinuation
Time frame: 24 months
To assess the effectiveness of Lecigon® treatment on the change in motor experiences of daily living from baseline up to 24 months, or treatment or study discontinuation as measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale II Scores (MDS-UPDRS II - motor experiences of daily living)
Change in Daily Levodopa dose from baseline up to 24 months, or treatment or study discontinuation
Time frame: 24 months
To assess the effectiveness of Lecigon® treatment on the change in Daily Levodopa dose [mg/day] from baseline up to 24 months, or treatment or study discontinuation as measured by morning bolus, continuous flow, extra boli, oral doses
Usage of other Anti-Parkinsonian medicinal products from baseline up to 24 months, or treatment or study discontinuation
Time frame: 24 months
To assess the effectiveness of Lecigon® treatment as measured by usage of other anti-Parkinsonian medicinal products (e.g. levodopa, dopamine agonists, Monoamine Oxidase (MAO)-B inhibitors, amantadine from baseline up to 24 months, or treatment or study discontinuation
Usage of the Lecigon® pump from baseline up to 24 months, or treatment or study discontinuation
Time frame: 24 months
To assess the effectiveness of Lecigon® treatment use of programmed pump rate (2 or 3 rates) from baseline up to 24 months, or treatment or study discontinuation will be collected
Change in Clinical Global Impression of Improvement (CGI-I) from baseline up to 24 months, or treatment or study discontinuation
Time frame: 24 months
To assess the effectiveness of Lecigon® treatment on the change in Clinical Global Impression of Improvement (CGI-I) from baseline up to 24 months, or treatment or study discontinuation as measured by Clinical Global Impression of Improvement Scale Score (CGI-I)
Change in Patient Global Impression of Change from baseline up to 24 months, or treatment or study discontinuation
Time frame: 24 months
To assess the effectiveness of Lecigon® treatment on the change in Patient Global Impression of Change (PGI-C) from baseline up to 24 months, or treatment or study discontinuation as measured by Patient Global Impression of Change Scale Score (PGI-C)
Satisfaction with treatment from baseline up to 24 months or treatment or study discontinuation
Time frame: 24 months
To assess the effectiveness with Lecigon®, satisfaction with treatment will be assessed in terms of pump size, weight, noise, handling and overall pump satisfaction from baseline up to 24 months or treatment or study discontinuation as measured by device satisfaction scale score between 0 (absolutely unsatisfied) to 10 (absolutely satisfied) for each item.
Occurrence of AEs and SAEs from baseline up to 24 months or treatment or study discontinuation
Time frame: 24 months
To assess the long-term safety of Lecigon® treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) (including drug-related, device- and procedure-related Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs), AEs of special interest) from time of Informed consent to study completion for up to 24 months or treatment or study discontinuation will be collected
5 secondary outcomes
Change in Non-Motor Symptoms from baseline up to 24 months, or treatment or study discontinuation
Time frame: 24 months
Change in Sleep Quality from baseline up to 24 months, or treatment or study Discontinuation
Time frame: 24 months
Change in Activities of daily living from baseline up to 24 months, or treatment or study discontinuation
Time frame: 24 months
Change in Quality of Life from baseline up to 24 months or treatment or study discontinuation
Time frame: 24 months
Usage of Healthcare resources from baseline up to 24 months, or treatment or study discontinuation
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
Related trials for Advanced Parkinson Disease
Not yet recruiting
Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.
Parkinson Disease
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
Not yet recruitingObservational study
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
Idiopathic Parkinson Disease
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
57 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Parkinson Disease, run by Britannia Pharmaceuticals Ltd. at 57 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Germany, Romania, Belgium, Spain, Austria and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in OFF time from baseline up to 24 months, or treatment or study discontinuation (time frame: 24 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.