Central neuropathic pain due to spinal cord injury, based on clinical history, clinical examination and appropriate assessment of patient’s signs and symptoms, according to the International Association for the Study of Pain (IASP) definition MedDRA version: 9.1 Level: LLT Classification code 10064012 Term: Central pain syndrome
Conditions
Interventions
Product Code: F13640
Pharmaceutical Form: Capsule, hard
CAS Number: 208110-64-9
Current Sponsor code: F13640
Concentration unit: mg mill
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Out patient or institutionalised patient, male or female- Aged > or = 18 years and 60 ml/mn - QTc less than the upper limit of the normal range at the selection - For the other laboratory safety tests and ECG parameters, normal or considered as not clinically significant, in the investigator’s opinion - Patient having given his/her written informed consent or his/her oral informed consent attested by a witness independent of the investigator and the sponsor, in case of motor function impairement in the arms - Patients affiliated to a social security system, or is a workers beneficiary (if applicable in the national regulation) - Patient able to read and understand the text on the PDA screen, able to hear the audible prompts, and able to use a PDA device daily for the whole duration of the study. If the patient is physically unable to use the PDA or to complete self-reporting questionnaires or scales, he/she should be assisted by identified caregivers. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - All conditions that can interfere with the pain assessment: presence of pain of other origin (nociceptive, inflammatory or peripheral neuropathic pain component) that could confound the assessment of central neuropathic pain related to SCI (for example if the intensity of pain of other origin is higher than the intensity of the neuropathic pain or if the patients are unable to distinguish between neuropathic pain and pain of other origin) - Demyelinating disease (multiple sclerosis…) - Complex Regional Pain Syndrome and other above level neuropathic pain - Pain related to complete cauda equina lesions - Refractory neuropathic pain (no response to more than 3 therapeutic classes well conducted, previously taken for central neuropathic pain) - Significant cognitive impairment on the investigator’s opinion - Severe dysautonomic tension instability - Uncontrolled arterial hypertension (SBP >140 mm Hg and/or DBP > 90 mm Hg) - Major depression requiring a pharmacological treatment - Diabetes mellitus - Any clinically significant hepatic, renal, respiratory, gastro-intestinal, cardiovascular, autoimmune, hematological, neurological or psychiatric history or current disease unrelated to the cause of neuropathic pain which may interfere with pain evaluation and the course of the study on the investigator’s opinion - History of alcohol or narcotic abuse within the 6 months preceding the selection or alcohol or narcotic dependence within the 2 years preceding the selection - Pregnancy or breast-feeding - Woman of childbearing potential who is unwilling or unable to use a medically accepted and well documented method of contraception (chirurgical or hormonal birth control or intrauterine device only) during 2 months before the inclusion in the study, during the whole duration of the study and up to 1 month after the last dose of the study treatment, in order to avoid pregnancy while being exposed to the study treatment A pregnancy test will be carried out at the selection visit, on D1 before initiation of the treatment, after the last administration of study treatment on D84 (or PW) and at the end of study visit Man able to father a child unwilling or unable to practice an effective mean of birth control while participating in this study and up to one month after the last dose of the study treatment - Intake of any unauthorized treatment which cannot be stopped - For patients having been treated by a prohibited treatment, a wash-out period of at least 5 T1/2 of the treatment must be respected prior to inclusion on D1- Patient with previous history of pharmacological sensitivity or hypersensitivity to 5-HT agonists - History of drug allergy or current allergic reaction - Patient in the exclusion period of a previous study (at least 5 T1/2 of the previous investigational product) - Patient involved in any other biomedical research during the study - Patient who could not be contacted in case of emergency - Is a family member or work associate (secretary, nurse, technician,…) of the Investigator - Mentally unable to understand the nature, objectives and possible consequen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of F13640 in spinal cord injury patients with moderate to severe central neuropathic pain, when administered for 12 weeks including a 7-day titration period.;Secondary Objective: To evaluate pain relief, impact on sleep, mood and motricity, safety and tolerability of F13640 in spinal cord injury patients with moderate to severe central neuropathic pain, when administered for 12 weeks including a 7-day titration period.;Primary end point(s): The primary criterion is the response to treatment defined as an average decrease from baseline, i.e. the last week before inclusion, of at least 30% on the 24-hour recall pain intensity score recorded on a Numeric Rating Scale by electronic diary within the last week before the end of treatment (D84 or premature withdrawal for any reason other than lack of efficacy); patients in whom the average daily dose of the intake of rescue medication during the last week before the end of treatment has increased by 15% or more compared to the last week before inclusion, will be considered as non responders. | — |
Countries
Belgium, Finland, France, Hungary, Italy, Netherlands, Spain
Outcome results
None listed