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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521048-39-00 | EU Trial (CTIS) Number |
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This study is a Phase III multicentric randomized controlled trial with parallel group design and waiting list in patients that have an indication to undergo intestinal L-Dopa + entacapone (Lecigon®) under the existing indication criteria (according to SmPC (Fachinformation) Lecigon®). As primary endpoint, we will analyze the difference of the pre-interventional baseline and 6-month follow-up on the "hyperdopaminergic symptoms" corresponding to section 3 of the "Ardouin Behavioural Scale" hypothesizing on the superiority of LECIG therapy compared to best medical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Best oral medical treatment: the patients in this arm will be continue the treatment they were in f | Active Comparator | Amog others L_DOPA + Decarboxymethylasehemmer Dopamine agonist Amantadine COMT-Inhibitors |
|
| Lecigon® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LECIG (levodopa, carbidopa, entacapone intestinal gel) | Drug | intestinal L-Dopa + entacapone (Lecigon®) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ardouin Behavioral Scale (hyperdopaminergic syndrome) | To show superiority of LECIG therapy compared to best medical treatment on "hyperdopaminergic symptoms" corresponding to Section 1 (items 2 & 4), and section 4 (all items) of the "Ardouin Behavioural Scale" between pre-interventional baseline and 6- month follow-up | 6 months |
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Inclusion Criteria:
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures. 2. Able to adhere to the study visit schedule and other protocol requirements. 3. Female Subject of childbearing potential1 and male subjects with female partner of childbearing potential1 is willing to use highly effective contraceptive methods during the study (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner2, sexual abstinence3).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Weiss, Prof | Contact | 0049 (0) 7071-29-82340 | Daniel.weiss@uni-tuebingen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DRK gemeinnützige Krankenhausgesellschaft mbH Saarland | Recruiting | Saarlouis | Saarland | 66740 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20457959 | Background | Weintraub D, Koester J, Potenza MN, Siderowf AD, Stacy M, Voon V, Whetteckey J, Wunderlich GR, Lang AE. Impulse control disorders in Parkinson disease: a cross-sectional study of 3090 patients. Arch Neurol. 2010 May;67(5):589-95. doi: 10.1001/archneurol.2010.65. | |
| 29452685 | Background | Lhommee E, Wojtecki L, Czernecki V, Witt K, Maier F, Tonder L, Timmermann L, Halbig TD, Pineau F, Durif F, Witjas T, Pinsker M, Mehdorn M, Sixel-Doring F, Kupsch A, Kruger R, Elben S, Chabardes S, Thobois S, Brefel-Courbon C, Ory-Magne F, Regis JM, Maltete D, Sauvaget A, Rau J, Schnitzler A, Schupbach M, Schade-Brittinger C, Deuschl G, Houeto JL, Krack P; EARLYSTIM study group. Behavioural outcomes of subthalamic stimulation and medical therapy versus medical therapy alone for Parkinson's disease with early motor complications (EARLYSTIM trial): secondary analysis of an open-label randomised trial. Lancet Neurol. 2018 Mar;17(3):223-231. doi: 10.1016/S1474-4422(18)30035-8. |
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| Best oral medication | Drug | Best oral medication |
|
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR | Recruiting | Dresden | Germany |
|
| Centre for Neurology, Department forNeurodegenerative Disease, and Hertie-Institute forClinical Brain Research | Recruiting | Tübingen | 72076 | Germany |
|
| Parkinson-Klinik Ortenau GmbH & Co. KG | Recruiting | Wolfach | Germany |
|
| 31006550 | Background | Weintraub D, Mamikonyan E. The Neuropsychiatry of Parkinson Disease: A Perfect Storm. Am J Geriatr Psychiatry. 2019 Sep;27(9):998-1018. doi: 10.1016/j.jagp.2019.03.002. Epub 2019 Mar 9. |
| 20880751 | Background | Calabresi P, Di Filippo M, Ghiglieri V, Tambasco N, Picconi B. Levodopa-induced dyskinesias in patients with Parkinson's disease: filling the bench-to-bedside gap. Lancet Neurol. 2010 Nov;9(11):1106-17. doi: 10.1016/S1474-4422(10)70218-0. Epub 2010 Sep 27. |
| 36087571 | Background | Weiss D, Ebersbach G, Moller JC, Schwarz J, Arlt C, Fritz B, Sensken SC, Eggert K. Do we start too late? Insights from the real-world non-interventional BALANCE study on the present use of levodopa/carbidopa intestinal gel in advanced Parkinson's disease in Germany and Switzerland. Parkinsonism Relat Disord. 2022 Oct;103:85-91. doi: 10.1016/j.parkreldis.2022.08.018. Epub 2022 Aug 24. |
| 40129359 | Background | Weiss D, Jost WH, Szasz JA, Pirtosek Z, Milanov I, Tomantschger V, Kovacs N, Staines H, Amlani B, Smith N, van Laar T. Levodopa-Entacapone-Carbidopa Intrajejunal Infusion in Advanced Parkinson's Disease - Interim Analysis of the ELEGANCE Study. Mov Disord Clin Pract. 2025 Aug;12(8):1075-1085. doi: 10.1002/mdc3.70046. Epub 2025 Mar 25. |
| 34235776 | Background | Weiss D, Volkmann J, Fasano A, Kuhn A, Krack P, Deuschl G. Changing Gears - DBS For Dopaminergic Desensitization in Parkinson's Disease? Ann Neurol. 2021 Nov;90(5):699-710. doi: 10.1002/ana.26164. Epub 2021 Jul 20. |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007980 | Levodopa |
| D002230 | Carbidopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
| D008750 | Methyldopa |
| D006834 | Hydrazines |
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