Pedal : identification of models for duodenal administration of levodopa
Document identifier: oai:dalea.du.se:1918
Keyword: Pharmacokinetic,
Pharmacodynamic,
Dose response model,
Simulation,
Identification,
Estimation,
Clinical study,
Parkinson,
Duodopa,
Levodopa infusionPublication year: 2006Relevant Sustainable Development Goals (SDGs):
The SDG label(s) above have been assigned by OSDG.aiAbstract: Backgound and aims: The main purpose of the PEDAL study is to identify and estimate sample individual pharmacokinetic- pharmacodynamic (PK/PD) models for duodenal infusion of levodopa/carbidopa (Duodopa®) that can be used for in numero simulation of treatment strategies. Other objectives are to study the absorption of Duodopa® and to form a basis for power calculation for a future larger study. PK/PD based on oral levodopa is problematic because of irregular gastric emptying. Preliminary work with data from [Gundert-Remy U et al. Eur J Clin Pharmacol 1983;25:69-72] suggested that levodopa infusion pharmacokinetics can be described by a two-compartment model. Background research led to a hypothesis for an effect model incorporating concentration-unrelated fluctuations, more complex than standard E-max models. Methods: PEDAL involved a few patients already on Duodopa®. A bolus dose (normal morning dose plus 50%) was given after a washout during night. Data collection continued until the clinical effect was back at baseline. The procedure was repeated on two non-consecutive days per patient. The following data were collected in 5 to 15 minutes intervals: i) Accelerometer data. ii) Three e-diary questions about ability to walk, feelings of “off” and “dyskinesia”. iii) Clinical assessment of motor function by a physician. iv) Plasma concentrations of levodopa, carbidopa and the metabolite 3-O-methyldopa. The main effect variable will be the clinical assessment. Results: At date of abstract submission, lab analyses were currently being performed. Modelling results, simulation experiments and conclusions will be presented in our poster.
Authors
Jerker Westin
Högskolan Dalarna; Datateknik
Other publications
>>
Thomas Willows
Other publications
>>
Torgny Groth
Other publications
>>
Mark Dougherty
Högskolan Dalarna; Datateknik
Other publications
>>
Mats Karlsson
Other publications
>>
Sven Pålhagen
Other publications
>>
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header:
identifier: oai:dalea.du.se:1918
datestamp: 2021-04-15T12:25:33Z
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recordCreationDate: 2006-03-07
identifier: http://urn.kb.se/resolve?urn=urn:nbn:se:du-1918
titleInfo:
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lang: eng
title: Pedal : identification of models for duodenal administration of levodopa
abstract: Backgound and aims: The main purpose of the PEDAL study is to identify and estimate sample individual pharmacokinetic- pharmacodynamic (PK/PD) models for duodenal infusion of levodopa/carbidopa (Duodopa®) that can be used for in numero simulation of treatment strategies. Other objectives are to study the absorption of Duodopa® and to form a basis for power calculation for a future larger study. PK/PD based on oral levodopa is problematic because of irregular gastric emptying. Preliminary work with data from Gundert-Remy U et al. Eur J Clin Pharmacol 1983;25:69-72 suggested that levodopa infusion pharmacokinetics can be described by a two-compartment model. Background research led to a hypothesis for an effect model incorporating concentration-unrelated fluctuations more complex than standard E-max models. Methods: PEDAL involved a few patients already on Duodopa®. A bolus dose (normal morning dose plus 50%) was given after a washout during night. Data collection continued until the clinical effect was back at baseline. The procedure was repeated on two non-consecutive days per patient. The following data were collected in 5 to 15 minutes intervals: i) Accelerometer data. ii) Three e-diary questions about ability to walk feelings of “off” and “dyskinesia”. iii) Clinical assessment of motor function by a physician. iv) Plasma concentrations of levodopa carbidopa and the metabolite 3-O-methyldopa. The main effect variable will be the clinical assessment. Results: At date of abstract submission lab analyses were currently being performed. Modelling results simulation experiments and conclusions will be presented in our poster.
subject:
@attributes:
lang: eng
topic: Pharmacokinetic
@attributes:
lang: eng
topic: pharmacodynamic
@attributes:
lang: eng
topic: dose response model
@attributes:
lang: eng
topic: simulation
@attributes:
lang: eng
topic: identification
@attributes:
lang: eng
topic: estimation
@attributes:
lang: eng
topic: clinical study
@attributes:
lang: eng
topic: Parkinson
@attributes:
lang: eng
topic: Duodopa
@attributes:
lang: eng
topic: levodopa infusion
language:
languageTerm: eng
genre:
conference/other
ref
note:
Published
6
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Westin
Jerker
role:
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affiliation:
Högskolan Dalarna
Datateknik
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jwe
0000-0003-0403-338X
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Willows
Thomas
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Groth
Torgny
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Dougherty
Mark
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Högskolan Dalarna
Datateknik
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Karlsson
Mats
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Pålhagen
Sven
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originInfo:
dateIssued: 2006
place:
placeTerm: Glasgow UK
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titleInfo:
title: European Journal of Neurology
part:
extent:
start: 220
end: 21
location:
url: http://du.diva-portal.org/smash/get/diva2:521578/FULLTEXT01.pdf
accessCondition: gratis
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form: electronic
typeOfResource: text