Study of Mirogabalin for Central Neuropathic Pain

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Daiichi Sankyo

Status and phase

Completed
Phase 3

Conditions

Central Neuropathic Pain

Treatments

Drug: Mirogabalin
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03901352
194653 (Registry Identifier)
DS5565-A-J314

Details and patient eligibility

About

Investigate the efficacy and safety of mirogabalin in participants with central neuropathic pain in comparison to placebo

Full description

[Double Blind Phase] The primary objective is to compare change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian participants with central neuropathic pain (central neuropathic pain after spinal cord injury) receiving mirogabalin versus placebo. [Open Extension Phase] The objective is to assess the long-term safety and efficacy of mirogabalin in participants with central neuropathic pain (central neuropathic pain after spinal cord injury, central post stroke pain, and central neuropathic pain in Parkinson's disease).

Enrollment

300 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Spinal cord injury (SCI) due to trauma
  • American Spinal Injury Association impairment scale A, B, C, or D

Exclusion criteria

  • Other severe pain at screening or randomization, unrelated to central neuropathic pain after SCI, that may confound the assessment of central neuropathic pain after SCI
  • Neurologic disorders at screening or randomization, unrelated to central neuropathic pain after SCI, that may confound the assessment of central neuropathic pain after SCI
  • Major psychiatric disorders within 1 year prior to screening

Trial design

300 participants in 2 patient groups, including a placebo group

Mirogabalin
Experimental group
Description:
The patients with creatinine clearance (CLcr) ≥ 60 mL/min: Mirogabalin 20 mg or 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose. The patients with creatinine clearance (CLcr) 30 to < 60 mL/min: Mirogabalin 10 mg or 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose
Treatment:
Drug: Mirogabalin
Placebo
Placebo Comparator group
Description:
Placebo (14-weeks)
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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