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Completed

NCT Number: NCT02989792

A Study to Investigate the Genetic Variation of Dopamine Pathway 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.

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Key information

Conditions

Peripheral Neuropathy Arthritis Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ATC SA, Liège, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling for genotyping

Genetic

Venous punction of maximum 10 millilitres

Personality Questionnaires completion

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tools4Patient

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 12, 2016
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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