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

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ClinicalTrials.gov Identifier: NCT02989792
Recruitment Status : Completed
First Posted : December 12, 2016
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Osteoarthritis Genetic: Blood sampling for genotyping Other: Personality Questionnaires completion Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : October 5, 2017
Actual Study Completion Date : October 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of participants with Single Nucleotide Polymorphisms (SNPs) variation of catechol-O-methyltransferase [ Time Frame: Time zero equals baseline ]
    SNPs will be analyzed with Sanger based genotyping or equivalent method

  2. Number of participants with SNPs variation of monoamine oxidase [ Time Frame: Time zero equals baseline ]
    SNPs will be analyzed with Sanger based genotyping or equivalent method

  3. Number of participants with SNPs variation of dopamine B hydroxylase [ Time Frame: Time zero equals baseline ]
    SNPs will be analyzed with Sanger based genotyping or equivalent method

  4. Number of participants with SNPs variation of dopamine receptor 3 [ Time Frame: Time zero equals baseline ]
    SNPs will be analyzed with Sanger based genotyping or equivalent method

  5. Number of participants with SNPs variation of brain-derived neurotropic factor genes [ Time Frame: Time zero equals baseline ]
    SNPs will be analyzed with Sanger based genotyping or equivalent method


Secondary Outcome Measures :
  1. Number of participants with SNPs variation of tryptophan hydroxylase-2 [ Time Frame: Time zero equals baseline ]
    SNPs will be analyzed with Sanger based genotyping or equivalent method

  2. Number of participants with SNPs variation of 5-hydroxytryptamine transporter [ Time Frame: Time zero equals baseline ]
    SNPs will be analyzed with Sanger based genotyping or equivalent method

  3. Number of participants with SNPs variation of 5-hydroxytryptamine receptor 2A [ Time Frame: Time zero equals baseline ]
    SNPs will be analyzed with Sanger based genotyping or equivalent method

  4. Number of participants with SNPs variation of serotonin transporter gene-linked polymorphic region genes [ Time Frame: Time zero equals baseline ]
    SNPs will be analyzed with Sanger based genotyping or equivalent method

  5. Number of participants with SNPs variation of opioid receptor gene [ Time Frame: Time zero equals baseline ]
    SNPs will be analyzed with Sanger based genotyping or equivalent method

  6. Number of participants with SNPs variation of fatty acid amid hydrolase gene [ Time Frame: Time zero equals baseline ]
    SNPs will be analyzed with Sanger based genotyping or equivalent method

  7. Assessment of Cronbach alpha of the personality questionnaire used in this study and the former ones [ Time Frame: Time zero equals baseline ]
    Cronbach's alpha between 0 and 1



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989792


Locations
Belgium
ATC SA
Liege, Belgium, 4000
France
CIC Clermont-Ferrand CHU G. Montpied
Clermont-Ferrand, France, 63003
Eurofins Optimed
Gieres, France, 38610
Institut Curie
Paris, France, 75005
Sponsors and Collaborators
Tools4Patient
Investigators
Study Director: Alvaro Pereira Tools4Patient

Responsible Party: Tools4Patient
ClinicalTrials.gov Identifier: NCT02989792     History of Changes
Other Study ID Numbers: T1001-03
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tools4Patient:
pain

Additional relevant MeSH terms:
Osteoarthritis
Chronic Pain
Peripheral Nervous System Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neuromuscular Diseases
Dopamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents