Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease

NCT07151378 | Recruiting Phase 3

• 2 other identifiers: INITIATE-LECIG2025-521048-39-00
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

LECIG; device assisted therapy; motor and non-motor fluctuations; dopaminergic complications; impulse control disorder; levodopa seeking; dopamine dysregulation syndrom; dopamine agonist; intestinal levodopa

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Drug: Best oral medication

Lecigon®

EXPERIMENTAL

Drug: LECIG (levodopa, carbidopa, entacapone intestinal gel)

Interventions

LECIG (levodopa, carbidopa, entacapone intestinal gel) DRUG

intestinal L-Dopa + entacapone (Lecigon®)

Lecigon®

Best oral medication DRUG

Best oral medication

Best oral medical treatment: the patients in this arm will be continue the treatment they were in f

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• For the purpose of this document, a female is considered of childbearing potential (FCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. For the purpose of this document, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy
• Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success
• In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. 4. All subjects must agree not to share medication. 5. Diagnosis of Idiopathic PD, inclusive of familial PD and genetic forms of L-Dopa responsive PD Age 18 - 75 years 7. Age at Parkinson's disease onset before 65 years 8. Disease duration ≥ 5 years 9. Oral medication constant for four weeks prior to baseline visit 10. Oral treatment with L-Dopa and non-ergot dopamine agonist(s) (any preparation, any dosage) 11. Presence of dopaminergic motor fluctuations based on patient history 12. Presence of dopaminergic neuropsychiatric (affective) fluctuations based on patient history 13. Presence of behavioural hyperdopaminergic syndrome including clinically relevant neuropsychiatric behavioural abnormalities according Ardouin Behavioural Scale Section 1, hypomanic symptoms, psychosis + Section 4 hyperdopaminergic behaviours (score ≥ 3), eventually further accompanied by impulse control disorders, a/o dopamine dysregulation, syndrome, a/o hallucination - psychosis spectrum; in case symptoms of the hallucination/psychosis or hypomania-mania spectrum are present, retained insight is mandatory at the time of study enrolment

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (7)

DRK gemeinnützige Krankenhausgesellschaft mbH Saarland

Saarlouis, Saarland, 66740, Germany

RECRUITING

Charité Campus Mitte

Berlin, Germany

RECRUITING

Knappschaft Kliniken Bottrop GmbH

Bottrop, Germany

NOT YET RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

Dresden, Germany

RECRUITING

University Hospital Marburg

Marburg, Germany

NOT YET RECRUITING

Centre for Neurology, Department forNeurodegenerative Disease, and Hertie-Institute forClinical Brain Research

Tübingen, 72076, Germany

RECRUITING

Parkinson-Klinik Ortenau GmbH & Co. KG

Wolfach, Germany

RECRUITING

Related Publications (7)

• 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.

  PMID: 20457959 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.

  PMID: 29452685 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.

  PMID: 31006550 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.

  PMID: 20880751 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.

  PMID: 36087571 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.

  PMID: 40129359 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.

  PMID: 34235776 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders

Interventions

Levodopa; Carbidopa

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Methyldopa; Hydrazines

Central Study Contacts

Daniel Weiss, Prof

CONTACT

0049 (0) 7071-29-82340; Daniel.weiss@uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: September 3, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): September 22, 2030
• Study Completion (Estimated): September 22, 2030
• Last Updated: July 13, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)