DESENSITIZE-PD: Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Support Dopaminergic Desensitization in PD

October 14, 2022 updated by: Daniel Weiss, University Hospital Tuebingen

DESENSITIZE-PD: Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Support Dopaminergic Desensitization in Parkinson's Disease

20 patients with idiopathic Parkinson's disease, who are planned to undergo intestinal L-Dopa + entacapone (Lecigon®) treatment will be included into this observational single-armed study. These patient will be observed for hyperdopaminergic complications and neuropsychiatric fluctuations postprocedure at 3, 6 and 12 months.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This study is planned as non-interventional observational single-armed study in patients that are planned to undergo intestinal L-Dopa + entacapone (Lecigon®) treatment as regular treatment choice outside the study protocol and under the accepted regulatory approval and indication criteria (according to German "Fachinformation Lecigon®"). Patients will be observed at the pre-interventional baseline (oral treatment, before treatment initiation with Lecigon®), 3-month, 6-month follow-up, and final 12-month follow-up. As primary interest, the investigator will analyze the contrast of the pre-interventional baseline and 12-month follow-up in terms of the Ardouin Behavioural Scale which evaluates the hyperdopaminergic complications and neuropsychiatric fluctuations in a semi-structured interview. As additional exploratory outcomes, the investigator will study the "Neuropsychiatric fluctuation scale", impulse control disorders with the "QUIP rating scale (QUIP-RS)". Moreover, the investigator will study apathy outcomes using the "Apathy Evaluation Scale" that mainly relates to the dopaminergic off-state. Outcomes of post-interventional apathy are particularly important, since i) they may coincide with hypodopaminergic off-states, and ii) since outcomes of postoperative apathy are a limitation of existing DBS therapy. Avoiding worsening of apathy might be a strength of intestinal L-Dopa therapy in this regard. Further, the investigator will study established measures of motor sensitization/de-sensitization in particular motor fluctuations and dyskinesia (MDS-UPDRS IV) and Unified Dyskinesia Rating Scale (UDysRS). For completeness, the investigator will characterize MDS-UPDRS III motor state in addition.

Since dopaminergic desensitization occurs with considerable delay of rather weeks and months after changing oral to continuous treatment, the investigator expect a reduction of dopaminergic motor and neuropsychiatric complications within the first 6 months from introducing Lecigon® together with a stable course until final 12-month follow-up. The outcomes will be decided as contrast of the pre-interventional baseline (V0) in best oral treatment compared to 12 month follow-up of Lecigon® treatment.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We will enroll patients with Parkinson's disease, who are eligible for intestinal treatment with Lecigon® as a regular treatment option outside of the study protocol and under the accepted eligibility and indication criteria.

Description

Inclusion Criteria:

  • Written declaration of consent
  • Age > 18 years and < 80 years
  • Idiopathic Parkinson's syndrome (according to British Brain Bank criteria), including genetic forms
  • L-dopa responsive Parkinson's syndrome
  • Duration of disease > 5 years
  • The treatment decision for Lecigon® was made as a regular treatment decision according to the established indication criteria outside the study
  • Motor fluctuations on oral dopaminergic therapy with uncontrolled motor off symptoms
  • Presence or history of dyskinesia based on available medical records or self-reported history

  • History of dopaminergic neuropsychiatric therapy complications based on available physician's letters or self-reported history:

    • impulse control disorders or
    • dopamine dysregulation syndrome or
    • off-condition apathy or
    • affective response fluctuations or
    • affective hypomanic or manic complications
    • hyperdopaminergic behavioral complications (such as binge eating or hobbyism or punding or increased creativity or risk seeking behavior; analogous to Ardouin Behaviour Scale Chapter IV - hyperdopaminergic behaviors).

Exclusion Criteria:

  • Dementia according to ICD-10 criteria; mild cognitive impairment (MCI) according to screening tools such as MoCA or MMSE is not considered an exclusion criterion as long as ICD-10 criteria for dementia are not met regardless of MoCA/MMSE score.
  • Acute paranoid psychosis or suicidality (however, impulse control disorder or dopamine dysregulation syndrome is not an exclusion criterion; illusions or (pseudo)-hallucinations are also not an exclusion criterion, as long as there is no risk to the patient or others according to clinical judgment; patients may be allowed to participate in the study after remission of the psychosis/suicidality)
  • Pregnancy

  • Contraindications to therapy with Lecigon® according the Summary of Product Characteristics (SmPC)

    • Hypersensitivity to the active ingredients of Lecigon®.
    • Narrow-angle glaucoma
    • Severe heart failure
    • Severe cardiac arrhythmia
    • Acute stroke
    • Severe impairment of liver function
    • Non-selective MAO inhibitors and selective type A MAO inhibitors must not be used concomitantly with Lecigon®. These inhibitors must have been discontinued at least two weeks prior to starting treatment with Lecigon®. Lecigon® may be used concomitantly with the manufacturer's recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline hydrochloride)
    • Conditions in which sympathomimetics (adrenergics) are contraindicated, e.g., pheochromocytoma, hyperthyroidism, and Cushing's syndrome.
    • Previous malignant neuroleptic syndrome (NMS) and/or nontraumatic rhabdomyolysis.
    • Suspected undiagnosed skin lesions or history of melanoma (levodopa could activate malignant melanoma).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ardouin Behavioural Scale
Time Frame: At baseline, 3 months, 6 months and 12 months, respectively

To evaluate the hyperdopaminergic complications and neuropsychiatric fluctuations from baseline to 12-months follow-up.

Minimum value: 0, maximum value: 84, higher score means worse outcome.
At baseline, 3 months, 6 months and 12 months, respectively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychiatric Fluctuation Scale
Time Frame: At baseline, 3 months, 6 months and 12 months, respectively

To identify and quantify neuropsychiatric fluctuations during motor fluctuations.

Minimum value for OFF items: 0, maximum value for OFF items: 30, higher score means worse outcome.

Minimum value for ON items: 0, maximum value for ON items: 30, higher score means worse outcome.
At baseline, 3 months, 6 months and 12 months, respectively
Questionnaire for impulsive-compulsive disorders in Parkinson's disease (QUIP)
Time Frame: At baseline, 3 months, 6 months and 12 months, respectively
To assess the severity of impulsive-compulsive disorders. Minimum value: 0, maximum value: 112, higher score means worse outcome.
At baseline, 3 months, 6 months and 12 months, respectively
Apathy Evaluation Scale
Time Frame: At baseline, 3 months, 6 months and 12 months, respectively
To quantify and characterize the apathy. Minimum value: 0, maximum value: 54, higher score means worse outcome.
At baseline, 3 months, 6 months and 12 months, respectively
Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Time Frame: At baseline, 3 months, 6 months and 12 months, respectively
To measure the severity of Parkinson symptoms. Minimum value: 0, maximum value: 132, higher score means worse outcome.
At baseline, 3 months, 6 months and 12 months, respectively
Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV
Time Frame: At baseline, 3 months, 6 months and 12 months, respectively
To measure the severity of motor complications. Minimum value: 0, maximum value: 24, higher score means worse outcome.
At baseline, 3 months, 6 months and 12 months, respectively
Unified Dyskinesia Rating Scale (UDyRS)
Time Frame: At baseline, 3 months, 6 months and 12 months, respectively
To evaluate involuntary movements. Minimum value: 0, maximum value: 104, higher score means worse outcome.
At baseline, 3 months, 6 months and 12 months, respectively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

STADAPHARM GmbH

Investigators

  • Principal Investigator: Daniel Weiss, MD, University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 10, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 14, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 388/2022BO2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

A study database will be established with our Institute for Clinical Epidemiology and Applied Biometry. Pseudonymized data can be made available after publication upon reasonable request to the Principal Investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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