Peripheral Neuropathies
Conditions
Keywords
Pain
Brief summary
The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response.
Interventions
BEHAVIORALHeat pain stimuli A
BEHAVIORALVideo A
This treatment is given as add on therapy to patients' regular analgesic
BEHAVIORALHeat pain stimuli B
BEHAVIORALVideo B
This treatment is given as add on therapy to patients' regular analgesic
Sponsors
Tools4Patient
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women of at least 18 years of age * Body weight of more than 40 kg and less than 120 kg with a BMI between 19-31 kg/m2 inclusive * Diagnosed with Peripheral Neuropathic Pain (PNP) since at least 6 months * Being affiliated with the national welfare system * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures * Have given written informed consent approved by the relevant Ethics Committee (EC) governing the study site PNP disease diagnosis inclusion criteria: * Patient with chronic PNP supported by a distinct neuroanatomical plausible distribution with sensory signs and symptoms, and consecutive to one of the following causes: a traumatic event, a surgical procedure (excluding limb amputation), radiculopathy, post-herpetic or post-zooster neuralgia, diabetic polyneuropathy or post-anticancer chemotherapy. Diagnosis will have to be confirmed by the DN4 questionnaire at the screening visit (pain is considered as neuropathic if DN4 score ≥ 4) * Pain present since at least 6 months * Patients will be required to have a score between 4 and 8 inclusive on the mean Average Pain Score (APS) Numeric Rating Scale (NRS) during the baseline period preceding randomization (data collected in patient diary) and to have completed at least 4 days of pain assessment
Exclusion criteria
* Pregnant, breastfeeding, or willing to be pregnant within 2 months * With a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the study * Uncontrolled epilepsy * Any current primary psychiatric condition, including major depression or major personality disorders (such as Axe II of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV); personality disorders and mental retardation) * Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine) * Acute disease state within 7 days before Visit 2 * Any other relevant medical disorder likely to interfere with the trial or represent a risk for the patient * Any close relationship with the Investigators or the Sponsor (i.e. belonging to immediate family or subordination link) * Patient under legal protection, according to the national law * Patient currently enrolled in a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or in an exclusion period according to national law
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment | Time zero equals baseline (Day 1) up to Day 42 | 11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS) | Time zero equals baseline (Day 1) up to Day 42 | 11-point Numeric Rating Scale (NRS) Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS |
| Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC) | Time zero equals baseline (Day 1) up to Day 28 | IGAC is an investigator subjective evaluation of patient condition using a NRS from 0 to 10 with 0 meaning best and 10 worst Lower values represent a better outcome. |
| Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period | Time zero equals baseline (Day 1) up to Day 28 | 11-point Numeric Rating Scale (NRS) from 0 to 10; 0 meaning no pain, 10 pain as bad as you can imagine Lower values represent a better outcome Unit: arithmetic average on 6 reported scores per Visit. |
| Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI). | Time zero equals baseline (Day 1) up to Day 28 | Arithmetic average of 3 questions on an 11-point Numeric Rating Scale (NRS) from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T4P1001 Heat pain stimuli A
Video A
Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic | 21 |
| Placebo Heat pain stimuli B
Video B
Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic | 21 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | T4P1001 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 10.3 | 55.5 years STANDARD_DEVIATION 12.7 | 56.8 years STANDARD_DEVIATION 11.5 |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 21 | 6 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment
11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS
Time frame: Time zero equals baseline (Day 1) up to Day 42
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T4P1001 | Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment | 0.87 units on a scale | Standard Deviation 1.49 |
| Placebo | Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment | 0.5 units on a scale | Standard Deviation 1.43 |
p-value: 0.416295% CI: [-0.5479411, 1.297601]t-test, 2 sided
Secondary
Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC)
IGAC is an investigator subjective evaluation of patient condition using a NRS from 0 to 10 with 0 meaning best and 10 worst Lower values represent a better outcome.
Time frame: Time zero equals baseline (Day 1) up to Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T4P1001 | Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC) | -0.15 units on a scale | Standard Deviation 1.755 |
| Placebo | Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC) | -0.95 units on a scale | Standard Deviation 2.459 |
p-value: 0.235395% CI: [-0.5457743, 2.1505362]t-test, 2 sided
Secondary
Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI).
Arithmetic average of 3 questions on an 11-point Numeric Rating Scale (NRS) from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome
Time frame: Time zero equals baseline (Day 1) up to Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T4P1001 | Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI). | 3.35 units on a scale | Standard Deviation 5.422 |
| Placebo | Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI). | 1.67 units on a scale | Standard Deviation 5.704 |
p-value: 0.338695% CI: [-1.83119, 5.197857]t-test, 2 sided
Secondary
Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS)
11-point Numeric Rating Scale (NRS) Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS
Time frame: Time zero equals baseline (Day 1) up to Day 42
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T4P1001 | Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS) | 0.78 units on a scale | Standard Deviation 1.45 |
| Placebo | Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS) | 0.65 units on a scale | Standard Deviation 1.53 |
p-value: 0.788795% CI: [-0.8152493, 1.0662697]t-test, 2 sided
Secondary
Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period
11-point Numeric Rating Scale (NRS) from 0 to 10; 0 meaning no pain, 10 pain as bad as you can imagine Lower values represent a better outcome Unit: arithmetic average on 6 reported scores per Visit.
Time frame: Time zero equals baseline (Day 1) up to Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T4P1001 | Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period | 0.76 units on a scale | Standard Deviation 1.003 |
| Placebo | Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period | -0.01 units on a scale | Standard Deviation 1.502 |
p-value: 0.0620495% CI: [-0.0406744, 1.5719601]t-test, 2 sided