A Study to Investigate the Genetic Variation of Dopamine Pathway in Patients With Chronic Pain

Study Overview
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Brief Summary
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Patients having completed former trials T1001-01 or T1001-02 will undergo one blood sampling for genotyping purposes. In addition they will compete the personality questionnaires they had completed in the former trial.

Official Title
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A Study to Investigate the Genetic Variation of Dopamine Pathway Associated With the Observed Effects of a New Treatment in Former Studies in Patients With Chronic Pain

Conditions
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Peripheral Neuropathy, Osteoarthritis

Intervention / Treatment
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* Genetic: Blood sampling for genotyping
* Other: Personality Questionnaires completion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have completed T1001-01 or T1001-02 study (Visit 5 completed) are men or women of at least 18 years of age have given written informed consent approved by the relevant Ethics Committee governing the study sites Exclusion Criteria: have any close relationship with the Investigators or the Sponsor are under legal protection, according to the national law

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Unique study arm<br> | Genetic: Blood sampling for genotyping<br>* Venous punction of maximum 10 millilitres<br>Other: Personality Questionnaires completion<br>* Completion of the following questionnaires: Multidimensional Personality Questionnaire (MPSQ), Interpersonal Reactivity Index (IRI) and Behavioral inhibition system/ Behavioral activation systems (BISBAS) questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Single Nucleotide Polymorphisms (SNPs) variation of catechol-O-methyltransferase | SNPs will be analyzed with Sanger based genotyping or equivalent method | Time zero equals baseline | 
| Number of participants with SNPs variation of monoamine oxidase | SNPs will be analyzed with Sanger based genotyping or equivalent method | Time zero equals baseline | 
| Number of participants with SNPs variation of dopamine B hydroxylase | SNPs will be analyzed with Sanger based genotyping or equivalent method | Time zero equals baseline | 
| Number of participants with SNPs variation of dopamine receptor 3 | SNPs will be analyzed with Sanger based genotyping or equivalent method | Time zero equals baseline | 
| Number of participants with SNPs variation of brain-derived neurotropic factor genes | SNPs will be analyzed with Sanger based genotyping or equivalent method | Time zero equals baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with SNPs variation of tryptophan hydroxylase-2 | SNPs will be analyzed with Sanger based genotyping or equivalent method | Time zero equals baseline | 
| Number of participants with SNPs variation of 5-hydroxytryptamine transporter | SNPs will be analyzed with Sanger based genotyping or equivalent method | Time zero equals baseline | 
| Number of participants with SNPs variation of 5-hydroxytryptamine receptor 2A | SNPs will be analyzed with Sanger based genotyping or equivalent method | Time zero equals baseline | 
| Number of participants with SNPs variation of serotonin transporter gene-linked polymorphic region genes | SNPs will be analyzed with Sanger based genotyping or equivalent method | Time zero equals baseline | 
| Number of participants with SNPs variation of opioid receptor gene | SNPs will be analyzed with Sanger based genotyping or equivalent method | Time zero equals baseline | 
| Number of participants with SNPs variation of fatty acid amid hydrolase gene | SNPs will be analyzed with Sanger based genotyping or equivalent method | Time zero equals baseline | 
| Assessment of Cronbach alpha of the personality questionnaire used in this study and the former ones | Cronbach's alpha between 0 and 1 | Time zero equals baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain