Clinical trial NCT02989792: A Study to Investigate the Genetic Variation of Dopamine Pathway in Patients With Chronic Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Osteoarthritis
Keywords: pain
Lead sponsor: Tools4Patient
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with Single Nucleotide Polymorphisms (SNPs) variation of catechol-O-methyltransferase
timeFrame: Time zero equals baseline
measure: Number of participants with SNPs variation of monoamine oxidase
timeFrame: Time zero equals baseline
measure: Number of participants with SNPs variation of dopamine B hydroxylase
timeFrame: Time zero equals baseline
measure: Number of participants with SNPs variation of dopamine receptor 3
timeFrame: Time zero equals baseline
measure: Number of participants with SNPs variation of brain-derived neurotropic factor genes
timeFrame: Time zero equals baseline
Secondary outcomes:
measure: Number of participants with SNPs variation of tryptophan hydroxylase-2
timeFrame: Time zero equals baseline
measure: Number of participants with SNPs variation of 5-hydroxytryptamine transporter
timeFrame: Time zero equals baseline
measure: Number of participants with SNPs variation of 5-hydroxytryptamine receptor 2A
timeFrame: Time zero equals baseline
measure: Number of participants with SNPs variation of serotonin transporter gene-linked polymorphic region genes
timeFrame: Time zero equals baseline
measure: Number of participants with SNPs variation of opioid receptor gene
timeFrame: Time zero equals baseline
measure: Number of participants with SNPs variation of fatty acid amid hydrolase gene
timeFrame: Time zero equals baseline
measure: Assessment of Cronbach alpha of the personality questionnaire used in this study and the former ones
timeFrame: Time zero equals baseline
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: ATC SA
city: Clermont-Ferrand
country: France
facility: CIC Clermont-Ferrand CHU G. Montpied
city: Gieres
country: France
facility: Eurofins Optimed
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: Tools4Patient
name: Alvaro Pereira
role: STUDY_DIRECTOR
References: