A Study to Investigate the Effects of a New Treatment in Patients With Chronic Pain

NCT02301169 | Completed Results

• 1 other identifier: T1001-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathies

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC)

  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

  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).

  Time zero equals baseline (Day 1) up to Day 28

Study Arms (2)

T4P1001

ACTIVE COMPARATOR

Behavioral: Heat pain stimuli A; Behavioral: Video A; Drug: Administration of T4P1001 capsules

Placebo

SHAM COMPARATOR

Behavioral: Heat pain stimuli B; Behavioral: Video B; Drug: Administration of placebo capsules

Interventions

Heat pain stimuli A BEHAVIORAL

T4P1001

Video A BEHAVIORAL

T4P1001

Administration of T4P1001 capsules DRUG

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

T4P1001

Heat pain stimuli B BEHAVIORAL

Placebo

Video B BEHAVIORAL

Placebo

Administration of placebo capsules DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Tools4Patient: lead

Study Sites (1)

CIC Clermont-Ferrand, CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Pain

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephanie Alvarez
• Organization: Tools4Patient

stephanie.alvarez@tools4patient.com

+32 71 14

Study Officials

• Alvaro Pereira

  Tools4Patient

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 25, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 28, 2017
• Results First Posted: May 16, 2016

Record last verified: 2017-12

Locations

FR (1)