Chronic PainQSPR-STRATNCT06244706
QSPainRelief-STRAT
A study testing Opioid drug + CNS-acting add-on drug in people with Chronic Pain and Analgesia, run by Université Catholique de Louvain.
Trial summary
Investigating the clinical outcomes of drug combinations (opioid + medication acting on the central nervous system) in patients suffering from persistent pain (pain lasting for at least three months) through patient-reported outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Analgesia, Adverse Drug Event
- What is being tested?
- Opioid drug + CNS-acting add-on drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 31 Dec 2025
- 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
- Aged over 18 years.
- Current treatment with an opioid for the treatment of pain, along with possible other drugs (see Table 1 for the list of eligible opioid medications - patients will be invited to indicate their treatment by selecting its name using a dropdown list).
- Decision by the treating physician to introduce an additional non-opioid CNS-acting treatment such as an antiepileptic, an anti-depressant or benzodiazepine (see Table 2 for the list of eligible medications - patients will be invited to indicate their treatment by selecting its name using a dropdown list).
- Capacity to understand and provide informed consent.
Who cannot join
- Insufficient French language skills.
- Epilepsy treated by an anti-epileptic.
- Alzheimer's disease.
- Parkinson's disease
- History of cancer diagnosed less than 5 years ago, treated by chemotherapy or radiotherapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: QSPainRelief-STRAT: A Questionnaire-based Evaluation of Perceived Clinical Outcome in Patients With Persistent Pain Receiving an Opioid and Non-opioid Treatment Combination, Stratified According to Age and Sex
Investigating the clinical outcomes of drug combinations (opioid + medication acting on the central nervous system) in patients suffering from persistent pain (pain lasting for at least three months) through patient-reported outcomes.
Read the detailed description
This study is part of the QSPainRelief project funded by the European Union's Horizon 2020 research and innovation program (grant agreement 848068; http://qspainrelief.eu).
The QSPainRelief project aims to setup, calibrate and validate a platform to predict the effects of treatment combinations according to patient characteristics such as age and sex (QSPainRelief platform) which integrates recently developed (1) physiologically based pharmacokinetic models to quantitate and adequately predict drug pharmacokinetics in human CNS, (2) target-binding kinetic models; (3) cellular signaling models and (4) a proprietary neural circuit model to quantitate the drug effects on the activity of relevant brain neuronal networks, that also adequately predicts clinical outcome.
To develop the QSPainrelief platform, a large dataset assessing perceived clinical outcome by real-world patients treated with a drug combination and stratified according to age and sex is required. To generate this dataset, we will conduct a questionnaire-based clinical study using an online platform (Redcap) and/or phone interviews to assess baseline patient characteristics and clinical outcome. Eligible patients are any patient treated with an opioid analgesic to whom an add-on treatment acting on the CNS is prescribed.
This study will focus on pain relief and its impact on daily life activities as therapeutic effects, and on drug-induced sedation, drug-induced cognitive dysfunction (memory and attention) and pain medication misuse as adverse effects. These adverse effects have been chosen because they can be readily assessed in patients after a short treatment period using validated patient-reported outcome measures (PROMs).
QSPainRelief-patientSTRAT is a monocentric prospective longitudinal questionnaire-based study conducted in patients suffering from persistent pain (pain lasting for at least three months), already treated with an opioid medication (treatment A) and to whom the treating physician is about to prescribe a CNS-acting add-on drug such as an antiepileptic, an antidepressant, a benzodiazepine or an alpha2-agonist (treatment B: the combination treatment).
- Conditions
- Chronic Pain, Analgesia, Adverse Drug Event, Drug Interaction
- Being tested
- Opioid drug + CNS-acting add-on drug
- Medical subject headings
- Chronic Pain, Agnosia, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid drug + CNS-acting add-on drugCombination product
Patients suffering from persistent pain (pain lasting for at least three months), already treated with an opioid medication (treatment A) and to whom the treating physician is about to prescribe a CNS-acting add-on drug such as an antiepileptic, an antidepressant, a benzodiazepine or an alpha2-agonist (treatment B: the combination treatment).
| Study group | Role | What they receive |
|---|---|---|
| Peristent Pain Patients | Other | Patients suffering from persistent pain (pain lasting for at least three months), already treated with an opioid medication (treatment A) and to whom the treating physician is about to prescribe a CNS-acting add-on drug such as an antiepileptic, an antidepressant, a benzodiazepine or an alpha2-agonist (treatment B: the combination treatment), will be included.
Evaluation of drug combination pain relief and its impact on daily life activities as therapeutic effects, and on drug-induced sedation and drug-induced cognitive dysfunction (memory and attention) as adverse effects will be evaluated through online (REDCap) patient-reported outcomes at the beginning of the study (day 0), 10 days and 3 months. Receives: Combination Product: Opioid drug + CNS-acting add-on drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
The intensity of pain at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences pain relief, expressed as change in pain severity score from Day 0 to Day 10 and Month 3 realized with the Brief Pain Inventory (SF-BPI) pain severity score.
Measured: 10 days and 3 months
Daily Life Activities
The impact on daily life activities at 10 days and 3 months post-drug combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences daily activities, expressed as change in daily life activities score from Day 0 to Day 10, and Month 3, realized with the Brief Pain Inventory (SF-BPI) daily life activities score.
Measured: 10 days and 3 months
Quality of Life (EURO-QoL)
The impact on quality of life at 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences quality of life, expressed as change in EuroQOL-5D score from Day 0 to Month 3.
Measured: 3 months
Drug-induced sedation
Drug-induced sedation at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences sleepiness, expressed as change in the Stanford Sleepiness Scale score from Day 0 to Day 10 and Month 3
Measured: 10 days and 3 months
Drug-induced cognitive dysfunction
. Drug-induced cognitive dysfunction (memory and attention) at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences cognitive functions, expressed as change in the PROMIS Neuro-QOL Short Form Cognitive Function score from Day 0 to Day 10 and Month 3.
Measured: 10 days and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244706
- Sponsor's protocol ID
- 2023/13/JUI/259
- Acronym
- QSPR-STRAT
- Status last verified
- Dec 2023
- First submitted
- 29 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QSPainRelief-STRAT: A Questionnaire-based Evaluation of Perceived Clinical Outcome in Patients With Persistent Pain Receiving an Opioid and Non-opioid Treatment Combination, Stratified According to Age and Sex
- ClinicalTrials.gov ID
- NCT06244706
- Acronym / sponsor ID
- QSPR-STRAT / 2023/13/JUI/259
- Conditions
- Chronic Pain, Analgesia, Adverse Drug Event, Drug Interaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Feb 2024 (actual)
- 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.
Investigating the clinical outcomes of drug combinations (opioid + medication acting on the central nervous system) in patients suffering from persistent pain (pain lasting for at least three months) through patient-reported outcomes.
Detailed description
This study is part of the QSPainRelief project funded by the European Union's Horizon 2020 research and innovation program (grant agreement 848068; http://qspainrelief.eu).
The QSPainRelief project aims to setup, calibrate and validate a platform to predict the effects of treatment combinations according to patient characteristics such as age and sex (QSPainRelief platform) which integrates recently developed (1) physiologically based pharmacokinetic models to quantitate and adequately predict drug pharmacokinetics in human CNS, (2) target-binding kinetic models; (3) cellular signaling models and (4) a proprietary neural circuit model to quantitate the drug effects on the activity of relevant brain neuronal networks, that also adequately predicts clinical outcome.
To develop the QSPainrelief platform, a large dataset assessing perceived clinical outcome by real-world patients treated with a drug combination and stratified according to age and sex is required. To generate this dataset, we will conduct a questionnaire-based clinical study using an online platform (Redcap) and/or phone interviews to assess baseline patient characteristics and clinical outcome. Eligible patients are any patient treated with an opioid analgesic to whom an add-on treatment acting on the CNS is prescribed.
This study will focus on pain relief and its impact on daily life activities as therapeutic effects, and on drug-induced sedation, drug-induced cognitive dysfunction (memory and attention) and pain medication misuse as adverse effects. These adverse effects have been chosen because they can be readily assessed in patients after a short treatment period using validated patient-reported outcome measures (PROMs).
QSPainRelief-patientSTRAT is a monocentric prospective longitudinal questionnaire-based study conducted in patients suffering from persistent pain (pain lasting for at least three months), already treated with an opioid medication (treatment A) and to whom the treating physician is about to prescribe a CNS-acting add-on drug such as an antiepileptic, an antidepressant, a benzodiazepine or an alpha2-agonist (treatment B: the combination treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peristent Pain Patients | Other | Combination Product: Opioid drug + CNS-acting add-on drugPatients suffering from persistent pain (pain lasting for at least three months), already treated with an opioid medication (treatment A) and to whom the treating physician is about to prescribe a CNS-acting add-on drug such as an antiepileptic, an antidepressant, a benzodiazepine or an alpha2-agonist (treatment B: the combination treatment), will be included. Evaluation of drug combination pain relief and its impact on daily life activities as therapeutic effects, and on drug-induced sedation and drug-induced cognitive dysfunction (memory and attention) as adverse effects will be evaluated through online (REDCap) patient-reported outcomes at the beginning of the study (day 0), 10 days and 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged over 18 years.
- Current treatment with an opioid for the treatment of pain, along with possible other drugs (see Table 1 for the list of eligible opioid medications - patients will be invited to indicate their treatment by selecting its name using a dropdown list).
- Decision by the treating physician to introduce an additional non-opioid CNS-acting treatment such as an antiepileptic, an anti-depressant or benzodiazepine (see Table 2 for the list of eligible medications - patients will be invited to indicate their treatment by selecting its name using a dropdown list).
- Capacity to understand and provide informed consent.
Key exclusion criteria (5 listed)
- Insufficient French language skills.
- Epilepsy treated by an anti-epileptic.
- Alzheimer's disease.
- Parkinson's disease
- History of cancer diagnosed less than 5 years ago, treated by chemotherapy or radiotherapy.
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 |
|---|---|---|
| Opioid drug + CNS-acting add-on drugPatients suffering from persistent pain (pain lasting for at least three months), already treated with an opioid medication (treatment A) and to whom the treating physician is about to prescribe a CNS-acting add-on drug such as an antiepileptic, an antidepressant, a benzodiazepine or an alpha2-agonist (treatment B: the combination treatment). | Combination product | Peristent Pain Patients |
Primary outcome
Pain Intensity
Time frame: 10 days and 3 months
The intensity of pain at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences pain relief, expressed as change in pain severity score from Day 0 to Day 10 and Month 3 realized with the Brief Pain Inventory (SF-BPI) pain severity score.
Daily Life Activities
Time frame: 10 days and 3 months
The impact on daily life activities at 10 days and 3 months post-drug combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences daily activities, expressed as change in daily life activities score from Day 0 to Day 10, and Month 3, realized with the Brief Pain Inventory (SF-BPI) daily life activities score.
Quality of Life (EURO-QoL)
Time frame: 3 months
The impact on quality of life at 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences quality of life, expressed as change in EuroQOL-5D score from Day 0 to Month 3.
Drug-induced sedation
Time frame: 10 days and 3 months
Drug-induced sedation at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences sleepiness, expressed as change in the Stanford Sleepiness Scale score from Day 0 to Day 10 and Month 3
Drug-induced cognitive dysfunction
Time frame: 10 days and 3 months
. Drug-induced cognitive dysfunction (memory and attention) at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences cognitive functions, expressed as change in the PROMIS Neuro-QOL Short Form Cognitive Function score from Day 0 to Day 10 and Month 3.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid drug + CNS-acting add-on drug in people with Chronic Pain and Analgesia, run by Université Catholique de Louvain.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact André Mouraux, Professor (0032496232399, andre.mouraux@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 10 days and 3 months). 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 6 Feb 2024.