Painful peripheral diabetic neuropathy MedDRA version: 8.1 Level: LLT Classification code 10012680 Term: Diabetic neuropathy
Conditions
Interventions
Product Code: TRO19622
Pharmaceutical Form: Capsule, hard
CAS Number: 22033-87-0
Current Sponsor code: TRO19622
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: -125
Sponsors
TROPHOS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be a male >18 years or a post-menopausal female (>60 years of age and at least 1 year of amenorrhea). 2. Have painful diabetic neuropathy of >6 months duration and have had a documented response to their neuropathic pain treatment (if not pain treatment naive). 3. Be on current pain medication (prescribed analgesics), stable for at least 3 months before study entry (± 25% dosage of basic pain medication, top-up rescue medication allowed), or pain treatment naive. 4. Have stable diabetes, defined as HbA1c 2 points on the Michigan Neuropathy Screening Instrument (MNSI), part B-physical assessment by health professional. 6. Have a normal electrocardiogram (ECG) The following inclusion criteria should be ascertained at the baseline visit: 7. Have measurable pain perception (previous 24h) on the Likert numerical rating scale with a mean =4.0 points calculated from at least 4 daily measurements over the 7 days immediately prior to the Baseline Visit. 8. Have stopped current pain medication at least 14 days prior to the Baseline Visit (except rescue medication). 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Be pregnant female, lactating female, or female of child bearing potential (=60 years of age). 2. Have a documented neuropathy of any cause other than those mentioned in the inclusion criteria which might interfere with the assessment of the severity of pain (eg, including, but not limited to, alcoholic, uremic, B12, TSH, chemotherapy, HIV, post surgical, or post-traumatic neuropathy). 3. Have other neurological diseases that may produce weakness, sensory loss, or autonomic symptoms, or laboratory test abnormality. 4. Have been on pain treatment with strong opioids, more than 4 different drug regimens in the previous year, or a current combination of more than 3 drugs. 5. Have a current medication of lipid lowering agents other than statins. 6. Have a body mass index (BMI) >40 kg/m2 (obesity grade III). 7. Had any surgery within the previous 2 months. 8. Have concurrent serious neurological disease (eg, dementia, multiple sclerosis, or any other disease that would impact the ability of the patient to provide consent for study participation). 9. Have a recent history (within the previous 6 months) or current evidence of alcohol or drug abuse. 10. Have concurrent unstable disease involving any system (eg, advanced carcinoma, acute myocardial infarction, renal failure, or any other condition that in the opinion of the Investigator would make the patient unsuitable for study participation). 11. Participated in any other investigational drug or therapy study within the previous 3 months. 12. Changed or interrupted current well-tolerated medication during the previous 3 months. 13. Lack of ability or willingness to give informed consent. 14. Be possibly dependent on the Investigator or the Sponsor (eg, including, but not limited to, affiliated employee). 15. Have hemostasis disorders or a current treatment of anticoagulants. 16. Have non-adequate renal and/or hepatic function as follows: • Renal – blood creatinine >1.5 × upper limit of normal (ULN) • Hepatic – liver enzymes (ALT and AST) >2 × ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the effect of TRO19622 versus placebo on the 24h neuropathic pain scores during the last 7 days of the 6-week treatment period. Therefore, the mean pain score during the last 7 days of the treatment period will be compared to the mean baseline pain during the last 7 days of the screening period ;Secondary Objective: Secondary objectives are to compare the efficacy on neuropathic pain, impact on emotional functioning, safety profile, pain time course, and response rate of TRO19622 versus placebo. Additionally, the pharmacokinetics of TRO19622 will be assessed.;Primary end point(s): The primary efficacy endpoint is the mean pain score during the last 7 days of the treatment period. | — |
Countries
Germany, Latvia
Outcome results
None listed