Diabetic Peripheral Neuropathic Pain
Conditions
Keywords
Diabetic peripheral neuropathic pain, Real-world evidence, Mirogabalin
Brief summary
This study will evaluate the safety and effectiveness of mirogabalin in adult patients with diabetic peripheral neuropathic pain (DPNP) in real-world clinical practice setting in China.
Detailed description
Mirogabalin has been approved in China for the treatment of DPNP. Although there is evidence of the safety and efficacy of mirogabalin, there is a lack of real-world evidence on its safety and effectiveness to inform decision-making among a more diverse patient population in real-world clinical practice, such as patients with moderate or severe renal impairment; patients with more complications, comorbidities, and treatments; and patients with different severity of pain. This study aims to collect safety and effectiveness data to guide physicians in the clinical use of mirogabalin for the treatment of patients with DPNP in the real-world clinical practice setting.
Interventions
OTHERNo Drug
This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol; however, participants on mirogabalin will be enrolled in this study.
Sponsors
Daiichi Sankyo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must meet all the following criteria to be eligible for this study. 1. Age ≥ 18 years at the time of informed consent form (ICF) signed. 2. Patients diagnosed with DPNP (defined as patients diagnosed with type 1 or type 2 diabetes and painful distal symmetric polyneuropathy). 3. Patients with a pain scale of visual analog scale (VAS( ≥ 40 mm on the day of ICF signed. 4. Patients who are mirogabalin naïve prior to ICF signed and planned to initiate mirogabalin treatment. 5. Patients who are able to give signed ICF for study participation and willing to provide access to previous and future medical information. Patients who meet any of the following criteria will be excluded from this study. 1. Patients who have other severe pain unrelated to DPN at baseline, which may confound the assessment of DPNP. 2. Patients who previously received pregabalin ≥ 300 mg/day or gabapentin ≥ 1200 mg/day to treat DPNP and declared lack of effectiveness. 3. Patients who received pregabalin, gabapentin, crisugabalin, or any other DPNP analgesic medications\* within 7 days prior to ICF signed. \*Other DPNP analgesic medication includes TCAs (amitriptyline, nortriptyline), SNRIs (duloxetine, venlafaxine), antiepileptics (carbamazepine), opioids (tapentadol, tramadol). 4. Patients with major psychiatric disorders (depression, Alzheimer disease, Parkinson disease, mania, bipolar disorder, psychosis, or schizophrenia, etc.) at baseline. 5. Patients with contraindications for mirogabalin treatment according to China package insert of mirogabalin. 6. Patients with simultaneous participation in any interventional clinical study. 7. Female patients at the status of pregnancy, potential pregnancy, or breast feeding. 8. Patients who have been judged by the investigator to be unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with any treatment related adverse events (TRAEs) | Baseline to Week 14 | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-onset of somnolence, dizziness, weight gain, and peripheral edema | Baseline to Week 14 | For time-to-event variables, the median time, Q1 and Q3 as well as 95% CI will be estimated. |
| Symptom duration of somnolence, dizziness, weight gain, and peripheral edema | Baseline to Week 14 | For time-to-event variables, the median time, Q1 and Q3 as well as 95% CI will be estimated. |
| Proportion of participants with TEAEs, serious TEAEs, TRAEs leading to study treatment discontinuation | Baseline to Week 14 | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Change from baseline in VAS pain | Week 14 | The VAS is used for the participant to rate average pain intensity of past 24 hours on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain. Reductions in VAS pain scores indicate better clinical outcome. |
| Proportion of participants achieving 30% and 50% pain relief (reduction in VAS score compared to baseline) | Baseline to Week 14 | The VAS is used for the participant to rate average pain intensity of past 24 hours on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain. Reductions in VAS pain scores indicate better clinical outcome. |
| Time to achieve 30% pain relief or 50% pain relief (reduction in VAS score compared to baseline) | Baseline to Week 14 | The VAS is used for the participant to rate average pain intensity of past 24 hours on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain. Reductions in VAS pain scores indicate better clinical outcome. |
| Change from baseline in Douleur Neuropathique 4 questions (DN4) score | Week 14 | DN4 will be assessed by the investigator after ICF signed and prior to the first administration of mirogabalin as baseline, when participants return to the clinical site during treatment period of mirogabalin, and at the end of mirogabalin treatment. Each "yes" answer is assigned 1 point, and a total score is calculated. A score of 4 or higher indicates a higher likelihood of neuropathic pain (eg. worse clinical outcome), while a score below 3 suggests it is less likely (eg. better clinical outcome). |
| Patient Global Impression of Change (PGIC) | Week 14 | Participants will provide a self-assessment using the 7-point scale via ePRO at the end of mirogabalin treatment: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse. Lower PGIC scores indicate better clinical outcome. |
| Change from baseline in EuroQol 5-Dimension 5-level (EQ-5D-5L) | Week 14 | The self-administered EQ-5D-5L includes the EQ-5D and the EQ VAS. EQ-5D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3-moderate problems, 4=severe problems and 5=extreme problems. The patient is asked to indicate his/her health state in each of the five dimensions, resulting in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Lower 5-digit numbers indicates better clinical outcome (ie, health state). The EQ VAS records the patient's self-rated health on a vertical VAS where the endpoints are labelled '100 - The best health you can imagine' and '0 - The worst health you can imagine'. Higher EQ VAS scores indicate better clinical outcome/health. |
Countries
China
Contacts
STUDY_DIRECTORProject Manager
Daiichi Sankyo Co., Ltd.
Outcome results
None listed