CompletedPhase 4

Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles

France225 participantsStarted 2012-10

Plain-language summary

This study is composed of a main study and an ancillary one. The objective of the main study is to define, on the psychopathological, neurological, pharmacokinetic and genetic plan, the predictive factors for developing a behavioural addiction (BA) secondarily to the dopaminergic treatment, associated or not to a dopamine dysregulation syndrome (DDS), in patients with Parkinson's disease. 3 particular profiles of patients will be established: * BA- : no secondary behavioural addiction * BA+/DDS-: secondary behavioural addiction, without dopamine dysregulation syndrome * BA+/DDS+: secondary behavioural addiction, with dopamine dysregulation syndrome We wish in particular: * To differentiate, among the BA+ subjects, those for who is a DDS from those for who we can evoke a side effect of the dopaminergic treatment * To demonstrate that the BA+/DDS- subjects present pharmacokinetic particularities causing the occurrence of the BA. * To clarify the possible relationship between the dosage and the pharmacodynamics of the treatment (especially that of pramipexole) in one hand, and the developing of BA in the other hand. * Demonstrate that the subjects BA + / DDS- are individually genetic vulnerability (related to the dopamine system), originally from the occurrence of the BA. This study has several levels of evaluation, we chose describe the methodology of the study in 3 axis : Psychopathology axis, Neurological axis and pharmacokinetic axis. The pharmacokinetic aspects will be studied only on a part of the sample, in an ancillary study centered on the pharmacokinetic of the pramipexole (in its immediate release form).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Main study Inclusion criteria: * To be 18 years old or more (both genders) * To have idiopathic Parkinson's disease, without important cognitive troubles, treated by usually prescribed drugs * To have a treatment established since 6 months at least Exclusion criteria: * To be under tutelage (a French protecting measure for persons with altered judgement) * To have a secondary Parkinson's disease * To have received a chirurgical treatment for Parkinson's disease * To present obvious cognitive disturbances Ancillary study (pharmacokinetic axis) : Inclusion criteria: * The same as the main study * To have a treatment by pramipexole in the immediate release form Exclusion criteria: * The same as the main study * Association of the pramipexole with others molecules * To use to have a behavioural addiction resolved by a diminution of the dosage before the study

What they're measuring

Psychopathological axis : score of sensation seeking (S Score) of the impulsivity questionnaire "UPPS"

Pharmacological axis : Area under the curve of the pramipexole concentration

Neurological axis : Unified Parkinson's Disease Rating Scale (UPDRS) III score

Genetic axis : distribution of allele frequencies and genotypic

Trial details

NCT IDNCT01733199

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05

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