Patients with neuropathic pain due to peripheral nerve injury
Conditions
Interventions
Product Name: PARENTIDE
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: PAR
CAS Number: 1202877-06-2
Other descriptive name: PAR
Concentration unit: mg milligra
Sponsors
BCN Peptides S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women between the ages of 18 and 85, both inclusive, at the time of signing the informed consent. 2. A woman will be eligible to participate in case of not being of childbearing age. If she is of childbearing age, she will have to commit to using one of the contraceptive methods listed in the protocol (Section 9.1 Contraceptive Requirements) for a suitable period to minimize the risk of pregnancy at that time. Women should commit to using these contraceptive methods up to 14 days after the last dose of study medication. Males should be committed to using the contraceptive methods listed in the protocol (Section 10.1 Contraceptive Requirements). This requirement should be followed from the time of administration of the first dose and up to 14 days after the last dose of study medication. 3. A diagnosis of peripheral neuropathic pain with the following characteristics: • Neuropathic pain confirmed from the "Douleur Neuropathique 4" questionnaire (DN4) • Focal neuropathic pain related to a nerve injury caused by surgery or trauma, not associated with an acute medical process, or avulsion injury (eg, neuropathic pain secondary to surgical procedures such as thoracotomy, mastectomy, inguinal hernia repair, and radical dissection of the Traumatic mononeuropathies and brachial plexus or lumbosacral injuries due to projectile injuries, lacerations, traffic accidents, etc.). • Localization of pain consistent with the area innervated by the affected nerve, with or without other sensory symptoms in the affected area. • The duration of pain should be at least 12 weeks from the initial injury. 4. Subjects receiving drugs to treat neuropathic pain (including tricyclic antidepressants, anticonvulsants, opioids, tramadol, bupropion, venlafaxine, mexiletine, NMDA antagonists), with the exception of NSAIDs, COX-2 inhibitors , Topical lidocaine, topical capsaicin, nerve blocks and steroid injections may only be included in the study if they received stable doses of these drugs for at least four weeks prior to baseline (day -7). 5. Subjects who have been receiving NSAIDs, COX-2 inhibitors and topical lidocaine may only be included in the study if they have discontinued these drugs for at least five half-lives (eg, 4 days for naproxen or 10h for Ibuprofen) before the basal period (day -7). In the case of topical capsaicin, the subjects should have suspended it for a minimum of eight weeks before the baseline period. 6. Subjects who have received nerve blocks or steroid injections for neuropathic pain may be included if their most recent treatment has been given at least four weeks prior to baseline (day -7). 7. Patients must be able to consistently report regions of dynamic allodynia and mechanical hyperalgesia. 8. Subjects must have a body mass index between 18.5 and 27 kg/m2. 9. The subject has given his/her full written informed consent before performing any procedure specified by the protocol, which includes compliance with the requirements and restrictions indicated in the consent document. 10. Normal ECG without pathologically relevant signs or with deviations that are not relevant according to the principal investigator's criteria. 11. The subject understands and is able to use the application "PARdolor" correctly, at the discretion of the investigator. 12. The subjects' baseline mean daily pain score on the 11-point numeric scale of pain intensity is = 6, calculated as the average of their daily scores (morning and evening) during the sev
Exclusion criteria
Exclusion criteria: 1. Pregnant women as determined by a positive urine hCG test at the time of screening or prior to administration or in breast-feeding. 2. Subjects with other causes of neuropathic pain, a considerable component of somatic pain, more than one cause or possible causes of painful symptoms, nerve entrapment, chronic neck or back pain of a greater than slight degree or any coexisting rheumatic disease, Such as fibromyalgia or rheumatoid arthritis. 3. Subjects with uncontrollable pain of unknown origin or active infection/inflammation in the area of ??nerve injury. 4. Subjects who have undergone extensive soft tissue injury associated with extensive surgery in the treatment of their nerve injury. 5. Drug and alcohol screening positive prior to study. However, a positive drug screening will not automatically exclude a subject if there is a medical explanation of the positive outcome other than drug addiction, Eg, a subject taking opioids to treat neuropathic pain. 6. Positive test for antibodies to HIV. 7. Positive test results for hepatitis B surface antigen or hepatitis C antibody test prior to study in the three months prior to screening. 8. History of any liver disease in the preceding six months. 9. Background of habitual excessive alcohol consumption in the six months prior to the study. 10. Background or presence of major cardiovascular, digestive or renal disease or other known process for interfering with the absorption, distribution, metabolism or excretion of drugs which, in the opinion of the investigator, could interfere with the study procedures or endanger the Security of the subject. 11. Background or presence of any clinically important anomalies in vital signs, ECGs or analytical tests or the existence of any medical or psychiatric process that, in the opinion of the investigator, could interfere with the study procedures or endanger the safety of the patient. 12. The subject has clinical data of recent major depression (according to medical history) except those already controlled with antidepressants at the time of selection. 13. Subjects who, according to the clinical criteria of the researcher, may be simulating the illness or motivated by a secondary gain derived from participation in the study will be excluded. Some examples where the exclusion will be considered are subjects with indemnity or social security claims pending in relation to their LNP or who have appealed against the denial of such claims, although it will not be necessary to exclude those whose claims have already been settled . 14. Modifications of medications allowed to treat neuropathic pain (section 6.2.1 Concomitant medications allowed) in the four weeks prior to baseline (day -7), such as dose adjustments, withdrawal of medication, or initiation of new medications. 15. Subjects who can not maintain the same medications to treat neuropathic pain at the same stable dose as in the baseline period during the study. 16. Inability to refrain from excessive use of sedatives (eg, benzodiazepines prescribed as hypnotics) which, in the opinion of the investigator, could interfere with efficacy or safety assessments. 17. Use of other over-the-counter or prescription drugs such as vitamins, herbal and dietary supplements within seven days (or 14 days if the drug is a potential enzyme inducer) or five half-lives (Whichever is longer) prior to the first dose of study medication or during the study, unless in the opinion of the investigator and the person in char
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the analgesic effect of repeated subcutaneous administration of PARENTIDE on neuropathic pain in patients with peripheral nerve injury due to surgery or trauma.;Secondary Objective: • Investigate the effect of repeated subcutaneous administration of PARENTIDE on dynamic allodynia and mechanical hyperalgesia. Also its effect on the patients' quality of life and sleep cycles. • Investigate the safety and tolerability of repeated subcutaneous administration of PARENTIDE. • Evaluate the pharmacokinetics of PARENTIDE and its metabolites.;Primary end point(s): Intensity of pain in the evening;Timepoint(s) of evaluation of this end point: Daily from V0 to V7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Intensity of pain in the morning • LANSS Neuropathic pain scale rating • Dynamic allodynia • Mechanical hyperalgesia • Perception of change • Interference of pain in sleep • Interference of pain in daily activity • SF-12 questionnaire score • Mood • Tiredness;Timepoint(s) of evaluation of this end point: • Intensity of pain in the morning. Daily from V0 to V7 • Neuropathic pain score on the LANSS scale. V0, V1, V2, V3, V4, V5, V6 and V7 • Dynamic allodynia. Selection, V0, V1, V2, V3, V4, V5, V6 and V7 • Mechanical hyperalgesia. Selection, V0, V1, V2, V3, V4, V5, V6 and V7 • Perception of change. V6 and V7 • Interference of pain in sleep. Daily from V0 to V7 • Interference of pain in daily activity. Daily from V0 to V7 • Score on the SF-12 questionnaire. V0 and V6 • Mood. Daily from V0 to V7 • Fatigue. Daily from V0 to V7 | — |
Countries
Spain
Contacts
Public ContactClinical Trial Info Desk
BCN Peptides S.A.
Outcome results
None listed