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

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 Overview

• Status: Completed
• Conditions: Peripheral Neuropathies
• Intervention / Treatment: Behavioral: Heat pain stimuli A; Behavioral: Video A; Drug: Administration of T4P1001 capsules; Behavioral: Heat pain stimuli B; Behavioral: Video B; Drug: Administration of placebo capsules

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CIC Clermont-Ferrand, CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Placebo	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
Active Comparator: T4P1001	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 zero equals baseline (Day 1) up to Day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 zero equals baseline (Day 1) up to Day 42
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 zero equals baseline (Day 1) up to Day 28
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 zero equals baseline (Day 1) up to Day 28
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 zero equals baseline (Day 1) up to Day 28

Collaborators and Investigators

• Sponsor: Tools4Patient
• Investigators: Study Director: Alvaro Pereira, Tools4Patient

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: November 14, 2014
• First Submitted That Met QC Criteria: November 21, 2014
• First Posted (Estimate): November 25, 2014

Study Record Updates

• Last Update Posted (Actual): December 28, 2017
• Last Update Submitted That Met QC Criteria: December 27, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: T1001-01