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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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