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Parkinson DiseaseNCT05579379

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

An observational study of Parkinson Disease, run by University Hospital Tuebingen.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson Disease
How many people
20 participants
Where
No sites listed yet
Study dates
Oct 2022to Sep 2024
Phase
Observational
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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
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  • 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).

Trial locations and contacts

No sites are listed yet.

Daniel T Weiss, MD contact

0049-7071-29-82340

daniel.weiss@uni-tuebingen.de

Idil Cebi, MD contact

0049-7071-29-85650

idil.cebi@med.uni-tuebingen.de

About this study

Official title: 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.

Read the 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.

Keywords
Parkinson's disease, dopaminergic sensitization, hyperdopaminergic complications, neuropsychiatric complications, intestinal L-Dopa therapy
Medical subject headings
Parkinson Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ardouin Behavioural Scale

    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.

    Measured: At baseline, 3 months, 6 months and 12 months, respectively

Secondary outcomes (6)

  1. Neuropsychiatric Fluctuation Scale

    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.

    Measured: At baseline, 3 months, 6 months and 12 months, respectively

  2. Questionnaire for impulsive-compulsive disorders in Parkinson's disease (QUIP)

    To assess the severity of impulsive-compulsive disorders. Minimum value: 0, maximum value: 112, higher score means worse outcome.

    Measured: At baseline, 3 months, 6 months and 12 months, respectively

  3. Apathy Evaluation Scale

    To quantify and characterize the apathy. Minimum value: 0, maximum value: 54, higher score means worse outcome.

    Measured: At baseline, 3 months, 6 months and 12 months, respectively

  4. Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III

    To measure the severity of Parkinson symptoms. Minimum value: 0, maximum value: 132, higher score means worse outcome.

    Measured: At baseline, 3 months, 6 months and 12 months, respectively

  5. Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV

    To measure the severity of motor complications. Minimum value: 0, maximum value: 24, higher score means worse outcome.

    Measured: At baseline, 3 months, 6 months and 12 months, respectively

  6. Unified Dyskinesia Rating Scale (UDyRS)

    To evaluate involuntary movements. Minimum value: 0, maximum value: 104, higher score means worse outcome.

    Measured: At baseline, 3 months, 6 months and 12 months, respectively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study startOct 2022 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

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
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05579379
Sponsor's protocol ID
388/2022BO2
Status last verified
Oct 2022
First submitted
10 Oct 2022
Last updated
18 Oct 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: 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

Publications

  • 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.

    PubMed 34235776

  • 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.

    PubMed 36087571

  • Schmitt E, Krack P, Castrioto A, Klinger H, Bichon A, Lhommee E, Pelissier P, Fraix V, Thobois S, Moro E, Martinez-Martin P. The Neuropsychiatric Fluctuations Scale for Parkinson's Disease: A Pilot Study. Mov Disord Clin Pract. 2018 Mar 23;5(3):265-272. doi: 10.1002/mdc3.12607. eCollection 2018 May-Jun.

    PubMed 30363450

  • Papay K, Mamikonyan E, Siderowf AD, Duda JE, Lyons KE, Pahwa R, Driver-Dunckley ED, Adler CH, Weintraub D. Patient versus informant reporting of ICD symptoms in Parkinson's disease using the QUIP: validity and variability. Parkinsonism Relat Disord. 2011 Mar;17(3):153-5. doi: 10.1016/j.parkreldis.2010.11.015. Epub 2010 Dec 24.

    PubMed 21186135

  • Probst CC, Winter LM, Moller B, Weber H, Weintraub D, Witt K, Deuschl G, Katzenschlager R, van Eimeren T. Validation of the questionnaire for impulsive-compulsive disorders in Parkinson's disease (QUIP) and the QUIP-rating scale in a German speaking sample. J Neurol. 2014 May;261(5):936-42. doi: 10.1007/s00415-014-7299-6. Epub 2014 Mar 9.

    PubMed 24609972

  • Weintraub D, Mamikonyan E, Papay K, Shea JA, Xie SX, Siderowf A. Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale. Mov Disord. 2012 Feb;27(2):242-7. doi: 10.1002/mds.24023. Epub 2011 Dec 1.

    PubMed 22134954

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by University Hospital Tuebingen.

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 15 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daniel T Weiss, MD (0049-7071-29-82340, daniel.weiss@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ardouin Behavioural Scale (time frame: At baseline, 3 months, 6 months and 12 months, respectively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05579379, which also lists 6 linked publications.

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 18 Oct 2022.

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