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/ALead Sponsor
Tools4PatientStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Peripheral NeuropathiesIntervention/Treatment
t4p1001 sodium chloride ...Study Participants
42The 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.
This treatment is given as add on therapy to patients' regular analgesic
This treatment is given as add on therapy to patients' regular analgesic
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
Event Type | Organ System | Event Term | T4P1001 | Placebo |
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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
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.
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
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.
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