Neuropathic pain develops as a result of damage to, or dysfunction of, the system that normally signals pain. It may arise from a heterogeneous group of disorders that affect the peripheral and central nervous systems. People with neuropathic pain may experience altered pain sensation, areas of numbness or burning, and continuous or intermittent evoked or spontaneous pain. In this study, neuropathic pain of diabetic origin is being investigated. MedDRA version: 18.1 Level: LLT Classification co
Conditions
Interventions
Product Name: PL37
Product Code: PL37
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: N/A
Current Sponsor code: PL37
Other descriptive name: PL37
Concentration unit: mg milligram(s)
Concentrat
Sponsors
Pharmaleads SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Willing and able to provide written informed consent prior to any study related procedures • Male or female, aged =18 years and =75 years • Willing to comply with all study procedures and be available for the duration of the study • Diagnosed (confirmed by pain specialist or endocrinologist) with peripheral neuropathic pain of diabetic origin • Neuropathic pain lasting for at least 3 months • Mean 24-hour average pain intensity score of 4 or higher, as calculated from a minimum of 5 NRS ratings recorded by the patient over the 7 days period after the screening and prior to the randomisation visit and also between the randomisation and the dispensing visit (this eligibility criterion will be provided by IVR system/ePRO diary) • Stable treatment with pregabalin or gabapentin for at least one month prior to screening visit • Adequately controlled diabetes (HbA1c = 10% or 86 mmol/ml) • Women of reproductive potential must use highly effective contraception from screening to 1 week after end of study treatment. (A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomised partner • Men of reproductive potential must use condoms from screening to 1 week after end of study treatment • HADS Depression score = 11 • Stable dose of any allowed central nervous system (CNS) - acting medications for at least one month prior to screening visit 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • Unstable angina, heart failure and significant pulmonary disease requiring home oxygen • Severe renal disease defined as eGFR 2.5 x ULN • Other painful medical conditions that could interfere with study outcomes (rheumatoid arthritis, inflammatory bowel disease, mechanical lower back disorders) • Use of disallowed concomitant medications (systemic analgesic, opioids or anti-inflammatory medications [other than paracetamol] or capsaicin cream during two weeks prior to screening visit) • Recent (last 2 weeks) febrile illness that precludes or delays participation • Inability to swallow study medication • Pregnant females as determined by positive urine pregnancy at randomisation visit • Breastfeeding females • Known hypersensitivity or intolerance to components of the study product(s) • Treatment with another investigational drug or other intervention during the last 4 weeks prior to screening visit • History of drug/alcohol abuse • History of severe psychiatric disorder • Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject’s full compliance with or completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of 200mg t.i.d. of PL37 + pregabalin or gabapentin compared to pregabalin or gabapentin plus placebo in the reduction of pain intensity in patients suffering from neuropathic pain of diabetic origin. ;Secondary Objective: To assess the safety/tolerability and efficacy of 200mg t.i.d. of PL37 + pregabalin or gabapentin compared to pregabalin or gabapentin plus placebo on: 1. Clinical and biological safety profile including occurrence of Adverse Events, the potential changes in vital signs, ECG and biological parameters. 2. Patient and clinician ratings of improvement and treatment satisfaction (Patient Global Impression of Change [PGIC] scale and the Clinical Global Impression of Change [CGIC, respectively]) 3. Changes in the nature of the patient’s subjective assessment of neuropathic pain (DN4 Questionnaire) 4. Changes in the patient’s subjective assessment of diabetic neuropathic pain (Michigan Neuropathy Screening Instrument [MNSI];Primary end point(s): Change in weekly mean of the 24-hour average pain intensity, self-assessed using the NRS for pain, and reported daily in the ePRO diary from baseline to end of treatment.;Timepoint(s) of evaluation of this end point: From baseline to end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety Endpoints: - Percentage of patients with treatment-emergent AEs - Change in ECG parameters from baseline - Change in Vital Sign parameters from baseline - Change in laboratory parameters from baseline Efficacy endpoints: - Proportion of patients who have "improved", "much improved" or "very much improved" relative to baseline on the Patient Global Impression of Change (PGIC) at end of treatment. - Proportion of patients who have "improved", "much improved" or "very much improved" relative to baseline on the Clinical Global Impression of Change (CGIC) at end of treatment. - Change in score of the patient’s subjective assessment of neuropathic pain from baseline to end of treatment, assessed by physician administered DN4 questionnaire, - Change in score of the patient’s subjective assessment of diabetic neuropathic pain from baseline to end of treatment, assessed by MNSI questionnaire. ;Timepoint(s) of evaluation of this end point: From baseline to end of treatment. | — |
Countries
Bulgaria, United Kingdom
Contacts
Public ContactMichel Wurm
Pharmaleads SA
Outcome results
None listed