Parkinson DiseaseBADGE-PDNCT02319395
Behavioural Addiction and Genetics in Parkinson's Disease
An observational study of Parkinson Disease and Impulse Control Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The " Behavioural Addiction and Genetics in Parkinson's Disease " study (BADGE-PD) is a national (France), multicenter, genetic association, case-control study to identify genetic factors associated with behavioural addiction (or Impulse Control Disorders, ICD) related to dopamine agonists treatment in Parkinson's… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Impulse Control Disorders
- What is being tested?
- Blood Sampling and DNA collection
- How many people
- 332 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Mar 2016
- Phase
- Observational
- 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
Study population: PD patients
Who may be able to join
- Case Group
- Age upper or equal to 30 years
- Caucasian European (2 parents and 4 grandparents born in Europe)
- Parkinson's disease according to the criteria of UKPDSBB
- With a behavioral addiction defined as:
- A score greater than or equal to 2 or 3 scores greater than or equal to 2 at hyperdopaminergic following items of Ardouin's scale (ECMP): eating behaviors, creativity, hobbyism, risk-taking behaviors, compulsive shopping, pathological gambling, hypersexuality, cyber-addiction, and Punding.
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- Onset under dopamine agonist or under L-DOPA
- Present at the inclusion visit
- OR in the past (<6 years). For these patients, the scale of Ardouin must have been passed at the time of behavior trouble or within 3 months after its disappearance.
- Affiliation to a social security
- Signature of the consent form
- Control Group
- Age upper or equal to 30 years
- Caucasian European (2 parents and 4 grandparents born in Europe)
- Parkinson's disease according to the criteria of UKPDSBB
- Time evolution of the disease than or equal to 5 years
- Having taken during its evolution a dopamine agonist dose at least equivalent to 300 mg of L-DOPA for at least 12 months.
- Not having behavioral addiction
- Not current, defined as a score of 0 or 1 and at most two items with a score of 1 on all items above and addiction to L-DOPA.
- Neither passed, given authenticated by the semi-structured interview retrospective finding a score of 0 or 1 on all items hyperdopaminergic of Ardouin's scale (see above) AND no more than two items with a score of 1 and addiction to L-DOPA.
- Affiliation to a social security
- Signature of the consent form
Who cannot join
- Case Group
- No Parkinson's disease or atypical parkinsonian syndrome
- Taking neuroleptic except clozapine for patients with AC
- Behavioral Addiction having started BEFORE taking the antiparkinsonian treatment
- Control Group
- No Parkinson's disease or atypical parkinsonian syndrome
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- Taking neuroleptic included clozapine for control patients
- Behavioral Addiction having started BEFORE taking the antiparkinsonian treatment
- Patient with guardianship, deprived of his liberty by judicial decision
Trial locations and contacts
1 site in 1 country.
About this study
The " Behavioural Addiction and Genetics in Parkinson's Disease " study (BADGE-PD) is a national (France), multicenter, genetic association, case-control study to identify genetic factors associated with behavioural addiction (or Impulse Control Disorders, ICD) related to dopamine agonists treatment in Parkinson's disease (PD). Polymorphisms of candidate genes supposed to be involved in this adverse effect will be compared in 200 PD patients with ICD (n=200) and 200 matched PD patients without ICD (n=200).
Read the detailed description
Objective: To identify susceptibility genes to impulse control disorders in Parkinson's Disease.
Study design: Genetic association study.
Primary objective:
To identify the susceptibility genes in behavior addiction in Parkinson's Disease
Secondary endpoints:
- To compare the clinical, neurological and psychiatric features of parkinsonian patients with behavior addiction compared to the control population. In case of differences between these groups, interaction will be studied with genetic factors
- Identify a psychometric profile from the TCI-R scale corresponding to the "hyperdopaminergic" subjects with AC personality
Patient selection:
Cases: patients with Parkinson's disease (PD) and impulse control disorder (ICD) as defined by a score greater than or equal to 2 or 3 scores greater than or equal to 2 at the "Evaluation Comportementale de la Maladie de Parkinson" scale (ECMP, Ardouin et al. 2009) for hyperdopaminergic items.
Controls: PD patients without impulse control disorder (ICD) as defined by a score of 0 or 1 at each hyperdopaminergic items AND no more than 2 items with a score of 1. Controls must have been treated with at least 300 mg of Levodopa equivalent daily dose for more than 12 months. Controls will be matched for sex, age, and age at onset of PD.
Number of subjects: 200 cases and 200 controls.
Clinical assessment: motor score (UPDRS), neuropsychological assessment, diagnostic criteria for addiction and ICD (MINI), self-administered psychometric questionnaire (TCI-R), treatment history, ICD history.
Genetic analysis: A blood sample will be taken for extraction and storage of DNA (DNA bank and Pitie-Salpetriere cells). Candidate genes* and polymorphisms will be selected from the literature data (receptors, transporters and metabolizing enzymes monoamine) and the molecular signature induced by L-DOPA in the striatum of a mice model of PD.
Statistical analysis:
A two-step analysis will be performed. For the first step, a training set (36% of subjects) will be analyzed with a logistic regression model considering an additive genetic effect. For the second step, the top 27% of the more significant genetic markers will be analyzed by using the left over replication set (64% of patients). Finally, a pooled analysis will be performed.
Sample Size: 200 patients per group to study 50 candidate markers with a power of 83% for genotype effect of 2.0, an additive genetic model, each allele frequency of 0.5.
- candidate genes list:
20 genes from the literature : DRD1, ANKK1, DRD2, DRD3, DRD4, DAT1, MAOA, COMT, HTR2A, HTR1B, TPH1, TPH2, 5HTT, GRIN2B, DBH, SCL6A2, BDNF, OPMR1, OPRK1, PDYN 8 genes from the experimentation: FosB, Arc, Nptx2, Ccrn4l, Car12, C8b, Mocs1, Mef2c
- Conditions
- Parkinson Disease, Impulse Control Disorders
- Being tested
- Blood Sampling and DNA collection
- Keywords
- Parkinson's Disease, Behaviour addiction, Dopamine agonist, Genetic.
- Medical subject headings
- Parkinson Disease, Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sampling and DNA collectionGenetic
One blood sampling during the study. A small number (1 to 5) of markers type "tag SNPs" or "coding SNP" " (single nucleotide polymorphism, SNP) will be selected for each of the selected genes, for a total of 50 markers (representing 20 to 25 genes). Non-silent coding SNP, that may have a functional effect, will be included as a priority. Genotyping is carried out by the method of genotyping VeraCode Goldengate.
| Study group | Role | What they receive |
|---|---|---|
| cases | Presence of ICD in PD patients (cases) is defined as a score ≥ 2 at 1 hyperdopaminegic item, or 2 scores ≥ 2 at 1 hyperdopaminergic item of the scale for assessment of behavior and mood in PD (ECMP). Receives: Genetic: Blood Sampling and DNA collection | |
| controls | Absence of ICD in PD patients (controls) is defined as a score ≤ 1 at all hyperdopaminergic items of ECMP and no more than 2 items of a score = 1. Receives: Genetic: Blood Sampling and DNA collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allele frequency of 50 genetic markers (polymorphisms) will be compared between cases and controls.
Measured: baseline
Secondary outcomes (5)
number of patients with a diagnostic of ICD according to the MINI
Measured: baseline
Total UPDRS (Unified Parkinson's Disease Rating Scale) score
Measured: baseline
Total score of the MMSE (Mini Mental State Examination)
Measured: baseline
Sub scores at the temperament and Character Inventory (revised version, TCI-R)
Measured: baseline
Number of subject in each group with personal or familial history of addiction
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startNov 2011
- Primary completionNov 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean-christophe Corvol, MD, PhD, Principal investigator, Assitance-Publique Hopitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319395
- Sponsor's protocol ID
- P100133
- Acronym
- BADGE-PD
- Status last verified
- Mar 2016
- First submitted
- 29 Sep 2014
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Addiction and Genetics in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02319395
- Acronym / sponsor ID
- BADGE-PD / P100133
- Conditions
- Parkinson Disease, Impulse Control Disorders
- Keywords
- Parkinson's Disease, Behaviour addiction, Dopamine agonist, Genetic.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Dec 2014 (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.
The " Behavioural Addiction and Genetics in Parkinson's Disease " study (BADGE-PD) is a national (France), multicenter, genetic association, case-control study to identify genetic factors associated with behavioural addiction (or Impulse Control Disorders, ICD) related to dopamine agonists treatment in Parkinson's disease (PD). Polymorphisms of candidate genes supposed to be involved in this adverse effect will be compared in 200 PD patients with ICD (n=200) and 200 matched PD patients without ICD (n=200).
Detailed description
Objective: To identify susceptibility genes to impulse control disorders in Parkinson's Disease.
Study design: Genetic association study.
Primary objective:
To identify the susceptibility genes in behavior addiction in Parkinson's Disease
Secondary endpoints:
- To compare the clinical, neurological and psychiatric features of parkinsonian patients with behavior addiction compared to the control population. In case of differences between these groups, interaction will be studied with genetic factors
- Identify a psychometric profile from the TCI-R scale corresponding to the "hyperdopaminergic" subjects with AC personality
Patient selection:
Cases: patients with Parkinson's disease (PD) and impulse control disorder (ICD) as defined by a score greater than or equal to 2 or 3 scores greater than or equal to 2 at the "Evaluation Comportementale de la Maladie de Parkinson" scale (ECMP, Ardouin et al. 2009) for hyperdopaminergic items.
Controls: PD patients without impulse control disorder (ICD) as defined by a score of 0 or 1 at each hyperdopaminergic items AND no more than 2 items with a score of 1. Controls must have been treated with at least 300 mg of Levodopa equivalent daily dose for more than 12 months. Controls will be matched for sex, age, and age at onset of PD.
Number of subjects: 200 cases and 200 controls.
Clinical assessment: motor score (UPDRS), neuropsychological assessment, diagnostic criteria for addiction and ICD (MINI), self-administered psychometric questionnaire (TCI-R), treatment history, ICD history.
Genetic analysis: A blood sample will be taken for extraction and storage of DNA (DNA bank and Pitie-Salpetriere cells). Candidate genes* and polymorphisms will be selected from the literature data (receptors, transporters and metabolizing enzymes monoamine) and the molecular signature induced by L-DOPA in the striatum of a mice model of PD.
Statistical analysis:
A two-step analysis will be performed. For the first step, a training set (36% of subjects) will be analyzed with a logistic regression model considering an additive genetic effect. For the second step, the top 27% of the more significant genetic markers will be analyzed by using the left over replication set (64% of patients). Finally, a pooled analysis will be performed.
Sample Size: 200 patients per group to study 50 candidate markers with a power of 83% for genotype effect of 2.0, an additive genetic model, each allele frequency of 0.5.
- candidate genes list:
20 genes from the literature : DRD1, ANKK1, DRD2, DRD3, DRD4, DAT1, MAOA, COMT, HTR2A, HTR1B, TPH1, TPH2, 5HTT, GRIN2B, DBH, SCL6A2, BDNF, OPMR1, OPRK1, PDYN 8 genes from the experimentation: FosB, Arc, Nptx2, Ccrn4l, Car12, C8b, Mocs1, Mef2c
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Genetic: Blood Sampling and DNA collectionPresence of ICD in PD patients (cases) is defined as a score ≥ 2 at 1 hyperdopaminegic item, or 2 scores ≥ 2 at 1 hyperdopaminergic item of the scale for assessment of behavior and mood in PD (ECMP). |
| controls | – | Genetic: Blood Sampling and DNA collectionAbsence of ICD in PD patients (controls) is defined as a score ≤ 1 at all hyperdopaminergic items of ECMP and no more than 2 items of a score = 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PD patients
Key inclusion criteria (22 listed)
- Case Group
- Age upper or equal to 30 years
- Caucasian European (2 parents and 4 grandparents born in Europe)
- Parkinson's disease according to the criteria of UKPDSBB
- With a behavioral addiction defined as:
Key exclusion criteria (9 listed)
- Case Group
- No Parkinson's disease or atypical parkinsonian syndrome
- Taking neuroleptic except clozapine for patients with AC
- Behavioral Addiction having started BEFORE taking the antiparkinsonian treatment
- Control Group
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 |
|---|---|---|
| Blood Sampling and DNA collectionOne blood sampling during the study. A small number (1 to 5) of markers type "tag SNPs" or "coding SNP" " (single nucleotide polymorphism, SNP) will be selected for each of the selected genes, for a total of 50 markers (representing 20 to 25 genes). Non-silent coding SNP, that may have a functional effect, will be included as a priority. Genotyping is carried out by the method of genotyping VeraCode Goldengate. | Genetic | cases, controls |
Primary outcome
Allele frequency of 50 genetic markers (polymorphisms) will be compared between cases and controls.
Time frame: baseline
5 secondary outcomes
number of patients with a diagnostic of ICD according to the MINI
Time frame: baseline
Total UPDRS (Unified Parkinson's Disease Rating Scale) score
Time frame: baseline
Total score of the MMSE (Mini Mental State Examination)
Time frame: baseline
Sub scores at the temperament and Character Inventory (revised version, TCI-R)
Time frame: baseline
Number of subject in each group with personal or familial history of addiction
Time frame: baseline
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 25 Jan 2017.
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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.
jean-christophe Corvol, MD, PhD principal investigator
Assitance-Publique Hopitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Impulse Control Disorders, run by Assistance Publique - Hôpitaux de Paris 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 22 inclusion and 9 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 25 Jan 2017. 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.
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?
Allele frequency of 50 genetic markers (polymorphisms) will be compared between cases and controls. (time frame: baseline). 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 25 Jan 2017.