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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02989792
Enrollment
110
Registered
2016-12-12
Start date
2017-02-08
Completion date
2017-10-05
Last updated
2019-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Peripheral Neuropathy

Keywords

pain

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.

Interventions

GENETICBlood sampling for genotyping

Venous punction of maximum 10 millilitres

OTHERPersonality Questionnaires completion

Completion of the following questionnaires: Multidimensional Personality Questionnaire (MPSQ), Interpersonal Reactivity Index (IRI) and Behavioral inhibition system/ Behavioral activation systems (BISBAS) questionnaires

Sponsors

Tools4Patient
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with Single Nucleotide Polymorphisms (SNPs) variation of catechol-O-methyltransferaseTime zero equals baselineSNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of monoamine oxidaseTime zero equals baselineSNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of dopamine B hydroxylaseTime zero equals baselineSNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of dopamine receptor 3Time zero equals baselineSNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of brain-derived neurotropic factor genesTime zero equals baselineSNPs will be analyzed with Sanger based genotyping or equivalent method

Secondary

MeasureTime frameDescription
Number of participants with SNPs variation of fatty acid amid hydrolase geneTime zero equals baselineSNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of tryptophan hydroxylase-2Time zero equals baselineSNPs 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 onesTime zero equals baselineCronbach's alpha between 0 and 1
Number of participants with SNPs variation of 5-hydroxytryptamine transporterTime zero equals baselineSNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of 5-hydroxytryptamine receptor 2ATime zero equals baselineSNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of serotonin transporter gene-linked polymorphic region genesTime zero equals baselineSNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of opioid receptor geneTime zero equals baselineSNPs will be analyzed with Sanger based genotyping or equivalent method

Countries

Belgium, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026