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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Peripheral Neuropathy
• Intervention / Treatment: Genetic: Blood sampling for genotyping; Other: Personality Questionnaires completion

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium, 4000
    • ATC SA
• France
  • Clermont-Ferrand, France, 63003
    • CIC Clermont-Ferrand CHU G. Montpied
  • Gieres, France, 38610
    • Eurofins Optimed
  • Paris, France, 75005
    • Institut Curie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tools4Patient
• Investigators: Study Director: Alvaro Pereira, Tools4Patient

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2017
• Primary Completion (Actual): October 5, 2017
• Study Completion (Actual): October 5, 2017

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimate): December 12, 2016

Study Record Updates

• Last Update Posted (Actual): May 8, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Chronic Pain; Peripheral Nervous System Diseases
• Other Study ID Numbers: T1001-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No