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

Primary Purpose

Peripheral Neuropathy, Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Blood sampling for genotyping
Personality Questionnaires completion
Sponsored by
Tools4Patient
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Peripheral Neuropathy focused on measuring pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ATC SA
  • CIC Clermont-Ferrand CHU G. Montpied
  • Eurofins Optimed
  • Institut Curie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Unique study arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants with SNPs variation of tryptophan hydroxylase-2
SNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of 5-hydroxytryptamine transporter
SNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of 5-hydroxytryptamine receptor 2A
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
SNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of opioid receptor gene
SNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of fatty acid amid hydrolase gene
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
Cronbach's alpha between 0 and 1

Full Information

First Posted
December 5, 2016
Last Updated
May 6, 2019
Sponsor
Tools4Patient
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1. Study Identification

Unique Protocol Identification Number
NCT02989792
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 8, 2017 (Actual)
Primary Completion Date
October 5, 2017 (Actual)
Study Completion Date
October 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tools4Patient

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Osteoarthritis
Keywords
pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unique study arm
Arm Type
Other
Intervention Type
Genetic
Intervention Name(s)
Blood sampling for genotyping
Intervention Description
Venous punction of maximum 10 millilitres
Intervention Type
Other
Intervention Name(s)
Personality Questionnaires completion
Intervention Description
Completion of the following questionnaires: Multidimensional Personality Questionnaire (MPSQ), Interpersonal Reactivity Index (IRI) and Behavioral inhibition system/ Behavioral activation systems (BISBAS) questionnaires
Primary Outcome Measure Information:
Title
Number of participants with Single Nucleotide Polymorphisms (SNPs) variation of catechol-O-methyltransferase
Description
SNPs will be analyzed with Sanger based genotyping or equivalent method
Time Frame
Time zero equals baseline
Title
Number of participants with SNPs variation of monoamine oxidase
Description
SNPs will be analyzed with Sanger based genotyping or equivalent method
Time Frame
Time zero equals baseline
Title
Number of participants with SNPs variation of dopamine B hydroxylase
Description
SNPs will be analyzed with Sanger based genotyping or equivalent method
Time Frame
Time zero equals baseline
Title
Number of participants with SNPs variation of dopamine receptor 3
Description
SNPs will be analyzed with Sanger based genotyping or equivalent method
Time Frame
Time zero equals baseline
Title
Number of participants with SNPs variation of brain-derived neurotropic factor genes
Description
SNPs will be analyzed with Sanger based genotyping or equivalent method
Time Frame
Time zero equals baseline
Secondary Outcome Measure Information:
Title
Number of participants with SNPs variation of tryptophan hydroxylase-2
Description
SNPs will be analyzed with Sanger based genotyping or equivalent method
Time Frame
Time zero equals baseline
Title
Number of participants with SNPs variation of 5-hydroxytryptamine transporter
Description
SNPs will be analyzed with Sanger based genotyping or equivalent method
Time Frame
Time zero equals baseline
Title
Number of participants with SNPs variation of 5-hydroxytryptamine receptor 2A
Description
SNPs will be analyzed with Sanger based genotyping or equivalent method
Time Frame
Time zero equals baseline
Title
Number of participants with SNPs variation of serotonin transporter gene-linked polymorphic region genes
Description
SNPs will be analyzed with Sanger based genotyping or equivalent method
Time Frame
Time zero equals baseline
Title
Number of participants with SNPs variation of opioid receptor gene
Description
SNPs will be analyzed with Sanger based genotyping or equivalent method
Time Frame
Time zero equals baseline
Title
Number of participants with SNPs variation of fatty acid amid hydrolase gene
Description
SNPs will be analyzed with Sanger based genotyping or equivalent method
Time Frame
Time zero equals baseline
Title
Assessment of Cronbach alpha of the personality questionnaire used in this study and the former ones
Description
Cronbach's alpha between 0 and 1
Time Frame
Time zero equals baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvaro Pereira
Organizational Affiliation
Tools4Patient
Official's Role
Study Director
Facility Information:
Facility Name
ATC SA
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CIC Clermont-Ferrand CHU G. Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Eurofins Optimed
City
Gieres
ZIP/Postal Code
38610
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France

12. IPD Sharing Statement

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

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