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

NCT05579379 | Unknown DMC

• 1 other identifier: 388/2022BO2
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. These patient will be observed for hyperdopaminergic complications and neuropsychiatric fluctuations postprocedure at 3, 6 and 12 months.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; dopaminergic sensitization; hyperdopaminergic complications; neuropsychiatric complications; intestinal L-Dopa therapy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

• Neuropsychiatric Fluctuation Scale

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

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

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

• Apathy Evaluation Scale

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

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

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

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• STADAPHARM GmbH: collaborator

Related Publications (6)

• 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

• 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

• 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.

  PMID: 30363450 BACKGROUND

• 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.

  PMID: 21186135 BACKGROUND

• 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.

  PMID: 24609972 BACKGROUND

• 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.

  PMID: 22134954 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel Weiss, MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: October 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 18, 2022

Record last verified: 2022-10