E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Painful peripheral diabetic neuropathy | |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10012680 | E.1.2 | Term | Diabetic neuropathy | |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | 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 | |
E.2.2 | Secondary objectives of the trial | 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. | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 <10%, no changes in medication in the previous 3 months, and no new symptoms associated with diabetes in the previous 3 months. 5.Have scored >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). | |
E.4 | Principal 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 | |
E.5 End points |
E.5.1 | Primary end point(s) | The primary efficacy endpoint is the mean pain score during the last 7 days of the treatment period. | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 | The trial involves single site in the Member State concerned | No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |