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

Tools4Patient (Cognivia)

Status

Completed

Conditions

Peripheral Neuropathies

Treatments

Behavioral: Heat pain stimuli B

Behavioral: Video B

Drug: Administration of placebo capsules

Behavioral: Heat pain stimuli A

Drug: Administration of T4P1001 capsules

Behavioral: Video A

Study type

Interventional

Funder types

Other

Identifiers

NCT02301169

T1001-01

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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