Peripheral NeuropathyNCT02989792
A Study to Investigate the Genetic Variation of Dopamine Pathway in Patients With Chronic Pain
A study testing Blood sampling for genotyping and Personality Questionnaires completion in people with Peripheral Neuropathy and Osteoarthritis, run by Tools4Patient at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy, Osteoarthritis
- What is being tested?
- Blood sampling for genotyping and Personality Questionnaires completion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 8 Feb 2017to 5 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- have any close relationship with the Investigators or the Sponsor
- are under legal protection, according to the national law
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
CIC Clermont-Ferrand CHU G. Montpied
Clermont-Ferrand, 63003
Eurofins Optimed
Gières, 38610
Institut Curie
Paris, 75005
About this study
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
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.
- Conditions
- Peripheral Neuropathy, Osteoarthritis
- Being tested
- Blood sampling for genotyping, Personality Questionnaires completion
- Keywords
- pain
- Medical subject headings
- Peripheral Nervous System Diseases, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for genotypingGenetic
Venous punction of maximum 10 millilitres
Personality Questionnaires completionOther
Completion of the following questionnaires: Multidimensional Personality Questionnaire (MPSQ), Interpersonal Reactivity Index (IRI) and Behavioral inhibition system/ Behavioral activation systems (BISBAS) questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Unique study arm | Other | Not described Receives: Genetic: Blood sampling for genotyping; Other: Personality Questionnaires completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Single Nucleotide Polymorphisms (SNPs) variation of catechol-O-methyltransferase
SNPs will be analyzed with Sanger based genotyping or equivalent method
Measured: Time zero equals baseline
Number of participants with SNPs variation of monoamine oxidase
SNPs will be analyzed with Sanger based genotyping or equivalent method
Measured: 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
Measured: 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
Measured: 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
Measured: Time zero equals baseline
Secondary outcomes (7)
Number of participants with SNPs variation of tryptophan hydroxylase-2
SNPs will be analyzed with Sanger based genotyping or equivalent method
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Time zero equals baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start8 Feb 2017
- Primary completion5 Oct 2017
- Study completion5 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tools4Patient
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alvaro Pereira, Study director, Tools4Patient
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989792
- Sponsor's protocol ID
- T1001-03
- Status last verified
- May 2019
- First submitted
- 5 Dec 2016
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02989792
- Acronym / sponsor ID
- T1001-03
- Conditions
- Peripheral Neuropathy, Osteoarthritis
- Keywords
- pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tools4PatientUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 5 Oct 2017 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unique study arm | Other | Genetic: Blood sampling for genotyping, Other: Personality Questionnaires completion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- have any close relationship with the Investigators or the Sponsor
- are under legal protection, according to the national law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling for genotypingVenous punction of maximum 10 millilitres | Genetic | Unique study arm |
| Personality Questionnaires completionCompletion of the following questionnaires: Multidimensional Personality Questionnaire (MPSQ), Interpersonal Reactivity Index (IRI) and Behavioral inhibition system/ Behavioral activation systems (BISBAS) questionnaires | Other | Unique study arm |
Primary outcome
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
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
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
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
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
7 secondary outcomes
Number of participants with SNPs variation of tryptophan hydroxylase-2
Time frame: Time zero equals baseline
Number of participants with SNPs variation of 5-hydroxytryptamine transporter
Time frame: Time zero equals baseline
Number of participants with SNPs variation of 5-hydroxytryptamine receptor 2A
Time frame: Time zero equals baseline
Number of participants with SNPs variation of serotonin transporter gene-linked polymorphic region genes
Time frame: Time zero equals baseline
Number of participants with SNPs variation of opioid receptor gene
Time frame: Time zero equals baseline
Number of participants with SNPs variation of fatty acid amid hydrolase gene
Time frame: Time zero equals baseline
Assessment of Cronbach alpha of the personality questionnaire used in this study and the former ones
Time frame: Time zero equals baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alvaro Pereira study director
Tools4Patient
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling for genotyping and Personality Questionnaires completion in people with Peripheral Neuropathy and Osteoarthritis, run by Tools4Patient at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Single Nucleotide Polymorphisms (SNPs) variation of catechol-O-methyltransferase (time frame: Time zero equals baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.