Parkinson's DiseasePhase 4PARKADDNCT01733199
Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles
A Phase 4 study testing questionnaires in people with Parkinson's Disease and Secondary Behavioural Addiction, run by Nantes University Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Secondary Behavioural Addiction
- What is being tested?
- questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- The same as the main study
- To have a treatment by pramipexole in the immediate release form
Who cannot join
- 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) :
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles.
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:
Read more
- 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).
Read the detailed description
This is a monocentric study with a recruitment period comprised between October 2012 and April 2016. The recruitment occurs during the consultations in the service of neurology. If the subjects are eligible, the study is proposed to them, and an evaluation is fixed in the next days. This evaluation consists in an individual face-to-face interview based on standardized and semi-structured questionnaires, during approximately one and a half hour. It's focused on the different characteristics of Parkinson's disease, and on psychiatric and addictive co morbidities. The evaluation is completed by a set of self-administered questionnaires focused on impulsivity and Attention Deficit Hyperactivity Disorder (ADHD).
For the 80 patients participated to the ancillary study only, a blood sample will be realized when the patient will arrived, just before the intake of his treatment (to obtain the residual plasmatic concentration). A second sample will be realized at a different time for each patient, to cover the entirety of the kinetic between 2 intakes of pramipexole (immediate release form) via the entire sample. The second blood sample will be realized four hours after the first one at the most. After this second sample, the patient will have completed his participation to the study.
Secondly, monitoring including a self-questionnaire booklet and a saliva sample will be offered to all patients who completed the initial visit.
- Being tested
- questionnaires
- Keywords
- Parkinson's disease, Behavioural addictions, Pathological gambling, Dopamine agonist, Dopamine dysregulation syndrome, Pharmacokinetic, Pramipexole
- Medical subject headings
- Parkinson Disease, Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
Summons of patients and filling questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| BA- | Experimental | Patient with no secondary behavioural addiction Receives: Other: questionnaires |
| BA+/DDS- | Experimental | Patients with secondary behavioural addiction, without dopamine dysregulation syndrome Receives: Other: questionnaires |
| BA+/DDS+ | Experimental | Patients with secondary behavioural addiction and dopamine dysregulation syndrome Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychopathological axis : score of sensation seeking (S Score) of the impulsivity questionnaire "UPPS"
This choice is founded on the fact that patients suffering of DDS are described as being impulsive, misusing their anti-parkinsonism treatment in the purpose of stimulate themselves, suggesting they have a high level of sensation and novelty seeking.
Pharmacological axis : Area under the curve of the pramipexole concentration
Area under the curve of the pramipexole concentration in function of the time between 2 intakes of pramipexole.
Neurological axis : Unified Parkinson's Disease Rating Scale (UPDRS) III score
UPDRS III score, with axial under-score in ON and OFF DOPA (Parkinson's disease severity)
Genetic axis : distribution of allele frequencies and genotypic
Distribution of allele frequencies and genotypic
Secondary outcomes (14)
Treatments except the anti-parkinsonism ones
Psychopathological axis
drug misuse
Psychopathological axis
addiction and punding antecedents
Psychopathological axis
ADHD antecedents
Psychopathological axis
impulsivity profile
Psychopathological axis
Age of onset of the Parkinson's disease
Neurological axis
stage and form of the Parkinson's disease
Neurological axis included dyskinesia and involuntary abnormal movements
time course of Parkinson's disease
Neurological axis
family history of Parkinson's disease
Neurological axis
anti-parkinsonism treatments
Neurological axis
Residual plasmatic concentration of the pramipexole
Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
median pharmacokinetic parameters of pramipexole
Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
study of the hepatic and renal functions
Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
Physiopathological covariates
Pharmacological axis age, gender, weight, creatinine and prothrombin rates The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie GRALL-BRONNEC, Principal investigator, Nantes UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733199
- Sponsor's protocol ID
- RC12_0059
- Acronym
- PARKADD
- Status last verified
- Feb 2018
- First submitted
- 20 Nov 2012
- Last updated
- 15 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles.
- ClinicalTrials.gov ID
- NCT01733199
- Acronym / sponsor ID
- PARKADD / RC12_0059
- Keywords
- Parkinson's disease, Behavioural addictions, Pathological gambling, Dopamine agonist, Dopamine dysregulation syndrome, Pharmacokinetic, Pramipexole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a monocentric study with a recruitment period comprised between October 2012 and April 2016. The recruitment occurs during the consultations in the service of neurology. If the subjects are eligible, the study is proposed to them, and an evaluation is fixed in the next days. This evaluation consists in an individual face-to-face interview based on standardized and semi-structured questionnaires, during approximately one and a half hour. It's focused on the different characteristics of Parkinson's disease, and on psychiatric and addictive co morbidities. The evaluation is completed by a set of self-administered questionnaires focused on impulsivity and Attention Deficit Hyperactivity Disorder (ADHD).
For the 80 patients participated to the ancillary study only, a blood sample will be realized when the patient will arrived, just before the intake of his treatment (to obtain the residual plasmatic concentration). A second sample will be realized at a different time for each patient, to cover the entirety of the kinetic between 2 intakes of pramipexole (immediate release form) via the entire sample. The second blood sample will be realized four hours after the first one at the most. After this second sample, the patient will have completed his participation to the study.
Secondly, monitoring including a self-questionnaire booklet and a saliva sample will be offered to all patients who completed the initial visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BA- | Experimental | Other: questionnairesPatient with no secondary behavioural addiction |
| BA+/DDS- | Experimental | Other: questionnairesPatients with secondary behavioural addiction, without dopamine dysregulation syndrome |
| BA+/DDS+ | Experimental | Other: questionnairesPatients with secondary behavioural addiction and dopamine dysregulation syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- The same as the main study
- To have a treatment by pramipexole in the immediate release form
Key exclusion criteria (8 listed)
- 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
- The same as the main study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesSummons of patients and filling questionnaire. | Other | BA+/DDS+, BA+/DDS-, BA- |
Primary outcome
Psychopathological axis : score of sensation seeking (S Score) of the impulsivity questionnaire "UPPS"
This choice is founded on the fact that patients suffering of DDS are described as being impulsive, misusing their anti-parkinsonism treatment in the purpose of stimulate themselves, suggesting they have a high level of sensation and novelty seeking.
Pharmacological axis : Area under the curve of the pramipexole concentration
Area under the curve of the pramipexole concentration in function of the time between 2 intakes of pramipexole.
Neurological axis : Unified Parkinson's Disease Rating Scale (UPDRS) III score
UPDRS III score, with axial under-score in ON and OFF DOPA (Parkinson's disease severity)
Genetic axis : distribution of allele frequencies and genotypic
Distribution of allele frequencies and genotypic
14 secondary outcomes
Treatments except the anti-parkinsonism ones
drug misuse
addiction and punding antecedents
ADHD antecedents
impulsivity profile
Age of onset of the Parkinson's disease
stage and form of the Parkinson's disease
time course of Parkinson's disease
family history of Parkinson's disease
anti-parkinsonism treatments
Residual plasmatic concentration of the pramipexole
median pharmacokinetic parameters of pramipexole
study of the hepatic and renal functions
Physiopathological covariates
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie GRALL-BRONNEC principal investigator
Nantes UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing questionnaires in people with Parkinson's Disease and Secondary Behavioural Addiction, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychopathological axis : score of sensation seeking (S Score) of the impulsivity questionnaire "UPPS". The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.