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

Not Applicable

Completed

• Conditions: Peripheral Neuropathy; Osteoarthritis
• Interventions: Genetic: Blood sampling for genotyping; Other: Personality Questionnaires completion

• Registration Number: NCT02989792
• Lead Sponsor: Tools4Patient

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-12
• Study Start: 2017-02-08
• Primary Completion: 2017-10-05
• Study Completion: 2017-10-05
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Unique study arm	Blood sampling for genotyping	-
Unique study arm	Personality Questionnaires completion	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

ATC SA; 🇧🇪 Liege, Belgium

CIC Clermont-Ferrand CHU G. Montpied; 🇫🇷 Clermont-Ferrand, France

Eurofins Optimed; 🇫🇷 Gieres, France

Institut Curie; 🇫🇷 Paris, France