MovDisordV3, Main, Exploration, bibRecord, 004E23

A randomized, double‐blind study of a skin patch of a dopaminergic agonist, piribedil, in Parkinson's disease

Identifieur interne : 004E23 ( Main/Exploration ); précédent : 004E22; suivant : 004E24

A randomized, double‐blind study of a skin patch of a dopaminergic agonist, piribedil, in Parkinson's disease

Auteurs : Jean-Louis Montastruc [France] ; Marc Ziegler [France] ; Olivier Rascol [France] ; Muriel Malbezin [France]

Source :

Movement Disorders [ 0885-3185 ] ; 1999-03.

RBID : ISTEX:4265CEFE8BB9B36ABF97EF9B3CE6A2055BDB6E1D

Descripteurs français

Pascal (Inist)
- Agoniste, Antiparkinsonien, Chimiothérapie, Essai clinique phase II, Homme, Parkinson maladie, Patch, Piribédil, Récepteur dopaminergique, Système transdermique, Traitement.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Administration, Cutaneous, Adult, Aged, Aged, 80 and over, Agonist, Analysis of Variance, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (pharmacology), Antiparkinson agent, Chemotherapy, Dopamine Agonists (administration & dosage), Dopamine Agonists (pharmacology), Dopamine receptor, Double-Blind Method, Female, Human, Humans, Male, Middle Aged, Parkinson Disease (drug therapy), Parkinson disease, Parkinson's disease, Patch, Phase II trial, Piribedil, Piribedil (administration & dosage), Piribedil (pharmacology), Transdermal patch, Transdermal system, Treatment, Treatment Outcome.
MESH :
- chemical , administration & dosage : Antiparkinson Agents, Dopamine Agonists, Piribedil.
- chemical , pharmacology : Antiparkinson Agents, Dopamine Agonists, Piribedil.
- drug therapy : Parkinson Disease.
- Administration, Cutaneous, Adult, Aged, Aged, 80 and over, Analysis of Variance, Double-Blind Method, Female, Humans, Male, Middle Aged, Treatment Outcome.

Abstract

This randomized, double‐blind trial was designed to evaluate the efficacy of a transdermal system of piribedil on the motor symptoms of Parkinson's disease during 3 weeks of treatment administered to three different groups: placebo, one piribedil patch (1 PP), and two (2 PP) piribedil patches. Twenty‐seven patients with idiopathic Parkinson's disease, treated with L‐dopa but not sufficiently controlled, were included in this trial. The test treatment did not demonstrate any clinical efficacy on either the main end point (Unified Parkinson's Disease Rating Scale motor score) or the secondary end points (rigidity, bradykinesia, postural, and resting tremor scores). The main adverse events were nausea (11%), vomiting (7.4%), and malaise (7.4%) mainly observed in the placebo group (four of seven patients). The local acceptability of the transdermal system was good. Plasma piribedil concentrations at the end of treatment were 6.74 ± 1.10 and 9.31 ± 3.33 ng/mL in the 1 PP and 2 PP groups, respectively. These plasma levels could account for the lack of clinical efficacy, because a previous pharmacokinetics‐PD study conducted in parkinsonian patients and treated with the intravenous route demonstrated that the critical limits of activity on tremor were between 10 and 30 ng/mL.

Url:

https://api.istex.fr/document/4265CEFE8BB9B36ABF97EF9B3CE6A2055BDB6E1D/fulltext/pdf

DOI: 10.1002/1531-8257(199903)14:2<336::AID-MDS1021>3.0.CO;2-9

Affiliations:

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<term>Antiparkinson Agents (pharmacology)</term>
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<front><div type="abstract" xml:lang="en">This randomized, double‐blind trial was designed to evaluate the efficacy of a transdermal system of piribedil on the motor symptoms of Parkinson's disease during 3 weeks of treatment administered to three different groups: placebo, one piribedil patch (1 PP), and two (2 PP) piribedil patches. Twenty‐seven patients with idiopathic Parkinson's disease, treated with L‐dopa but not sufficiently controlled, were included in this trial. The test treatment did not demonstrate any clinical efficacy on either the main end point (Unified Parkinson's Disease Rating Scale motor score) or the secondary end points (rigidity, bradykinesia, postural, and resting tremor scores). The main adverse events were nausea (11%), vomiting (7.4%), and malaise (7.4%) mainly observed in the placebo group (four of seven patients). The local acceptability of the transdermal system was good. Plasma piribedil concentrations at the end of treatment were 6.74 ± 1.10 and 9.31 ± 3.33 ng/mL in the 1 PP and 2 PP groups, respectively. These plasma levels could account for the lack of clinical efficacy, because a previous pharmacokinetics‐PD study conducted in parkinsonian patients and treated with the intravenous route demonstrated that the critical limits of activity on tremor were between 10 and 30 ng/mL.</div>
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Movement Disorders (revue)

A randomized, double‐blind study of a skin patch of a dopaminergic agonist, piribedil, in Parkinson's disease

A randomized, double‐blind study of a skin patch of a dopaminergic agonist, piribedil, in Parkinson's disease

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

	Movement Disorders (revue)
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.