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

CompletedNot applicableNCT02301169
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

Official title
A Study to Investigate the Effects of T4P1001 Treatment in Patients With Peripheral Neuropathic Pain
Conditions
  • Peripheral Neuropathies
Interventions
  • 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
Sponsor
Tools4Patient
Start date
2014-03
Primary completion
2014-11
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
France
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 protectio…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02301169