A Study to Evaluate the Safety and Effectiveness of Mirogabalin in Chinese Adult Patients With Diabetic Peripheral Neuropathic Pain (DPNP) in Real-world Clinical Practice Setting (ReMIssion Study)

Daiichi Sankyo

Status: Enrolling

Conditions: Diabetic Peripheral Neuropathic Pain

Treatments: Other: No Drug

Study type: Observational

Funder types: Industry

Identifiers

NCT06812117

DS5565-0002-NIS-MA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 720 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

720 participants in 1 patient group

Diabetic peripheral neuropathic pain (DPNP)

Description:

Patients diagnosed with DPNP and newly treated with mirogabalin.

Treatment:

Other: No Drug