Title

A Study to Investigate the Effects of a New Treatment in Patients With Chronic Pain
A Study to Investigate the Effects of T4P1001 Treatment in Patients With Peripheral Neuropathic Pain
  • Phase

    N/A
  • Study Type

    Interventional
  • Intervention/Treatment

    t4p1001 sodium chloride ...
  • Study Participants

    42
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.
Study Started
Mar 31
2014
Primary Completion
Nov 30
2014
Study Completion
Nov 30
2014
Results Posted
May 16
2016
Estimate
Last Update
Dec 28
2017

Behavioral Heat pain stimuli A

Behavioral Video A

Drug Administration of T4P1001 capsules

This treatment is given as add on therapy to patients' regular analgesic

Behavioral Heat pain stimuli B

Behavioral Video B

Drug Administration of placebo capsules

This treatment is given as add on therapy to patients' regular analgesic

T4P1001 Active Comparator

Placebo Sham Comparator

Criteria

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

Exclusion criteria related to PNP:

Neuropathic pain due to trigeminal neuralgia, central pain, complex regional pain syndrome and phantom limb pain
Plan to have a session of physiotherapy or comportemental therapy such as gestion of pain, hypnosis, sophrology, meditation program during the study
Have initiated or have planned an electrical stimulation (or neurostimulation) therapy within 2 weeks prior to Visit 1 or during the study period up to Visit 5
Patient changed his/her " regular therapy " in the last 4 months

Summary

T4P1001

Placebo

All Events

Event Type Organ System Event Term T4P1001 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

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

T4P1001

0.87
units on a scale (Mean)
Standard Deviation: 1.49

Placebo

0.5
units on a scale (Mean)
Standard Deviation: 1.43

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

T4P1001

0.78
units on a scale (Mean)
Standard Deviation: 1.45

Placebo

0.65
units on a scale (Mean)
Standard Deviation: 1.53

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.

T4P1001

-0.15
units on a scale (Mean)
Standard Deviation: 1.755

Placebo

-0.95
units on a scale (Mean)
Standard Deviation: 2.459

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.

T4P1001

0.76
units on a scale (Mean)
Standard Deviation: 1.003

Placebo

-0.01
units on a scale (Mean)
Standard Deviation: 1.502

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

T4P1001

3.35
units on a scale (Mean)
Standard Deviation: 5.422

Placebo

1.67
units on a scale (Mean)
Standard Deviation: 5.704

Total

42
Participants

Age, Continuous

56.8
years (Mean)
Standard Deviation: 11.5

Sex: Female, Male

Overall Study

T4P1001

Placebo

Drop/Withdrawal Reasons

T4P1001