INITIATE-LECIG: Intestinal levodopa + entacapone therapy (Lecigon®) to counteract dopaminergic desensitization and neuropsychiatric complications in Parkinson’s disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Tuebingen AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

28 Oct 2025 → ongoing

Decision date (initial)

2025-08-04

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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

Secondary objectives 8

1. Evaluation of Neuropsychiatric fluctuation scale
2. Evaluation of QUIP rating scale (QUIP-RS) for impulse controldisorders
3. Apathy Evaluation Scale for apathy outcomes
4. Measures of motor sensitization/desensitizationMotor fluctuations and dyskinesia (MDS-UPDRS IV)Unified Dyskinesia Rating Scale (UDysRS)MDS-UPDRS III
5. Quality of life (PDQ-39)
6. Patient / physician global impression
7. Caregiver burden
8. MoCa Test

Conditions and MedDRA coding

Parkinson Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

1. 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
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
6. 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); as exception, patients not being treated with dopamine agonists may be enrolled in case they exhibit clinically-relevant impulse control disorder or dopamine-dysregulation syndrome (compulsory and addictive dopamine intake)
11. Presence of dopaminergic motor fluctuations based on patient histor
12. Preserved dopaminergic motor response of ≥ 30% according to MDS UPDRS III assessed in the practically defined dopaminergic Off and On conditions
13. Presence of dopaminergic neuropsychiatric (affective) fluctuations based on patient history
14. 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

Exclusion criteria 13

1. Women during pregnancy and lactation
2. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
3. History of entacapone-induced diarrhoea under oral entacapone (it is recommended to have tried oral entacapone before entering this study, but this is not mandatory)
4. Participation in other clinical trials or observation period of competing trials over the past three months
5. Patients suffering from cognitive impairment (MoCA < 21) will be excluded for the major reason to obtain valid Ardouin assessments that will be hampered in case cognitive impairment (and therefore insight) is too severe
6. Acute paranoid psychosis without retained insight (however impulse control disorder or dopamine dysregulation syndrome are not an exclusion criterion; illusions or (pseudo)-hallucinations are not an exclusion criterion as long as there is no endangerment of the patients themselves or other persons owing to clinical judgement; patients may be eligible after remission of psychosis/suicidality)
7. 7. Severe depression according to ICD-10 criteria; however, affective fluctuations with intermittent depressive symptoms (reversed by dopaminergic medication) are not an exclusion criterion
8. Active suicidality without self-distancing (however, suicidal ideation/thoughts or passive wishes of being dead are not an exclusion criterion as long as the patient is credibly distancing from it).
9. General contraindications for intestinal L-Dopa therapy (according to Lecigon® Fachinformation
10. Gastrointestinal contraindications against PEG-J tube or T-Port placement
11. Tremor-dominant PD without dopaminergic response fluctuations
12. Pre-existing device assisted therapy (DAT) immediately before study enrolment including with DBS, LCIG/LECIG, or subcutaneous therapy with apomorphine or foslevodopa; if patient terminated pre-existing subcutaneous therapy, the patient will be eligible after having received oral dopamine replacement therapy for at least 3 months
13. Malignancy in a non-remitted stage

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To show superiority of LECIG therapy compared to best medicaltreatment on “hyperdopaminergic symptoms” corresponding toSection 1 (items 2 & 4), and section 4 (all items) of the “ArdouinBehavioural Scale” between pre-interventional baseline and 6-month follow-up

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Tuebingen AöR

Sponsor organisation

Universitaetsklinikum Tuebingen AöR

Address

Geissweg 3, Innenstadt Innenstadt

City

Tuebingen

Postcode

72076

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Tuebingen AöR

Contact name

CRO

Public contact point

Organisation

Universitaetsklinikum Tuebingen AöR

Contact name

CRO

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications