Phase 3
N=300
Study of Mirogabalin for Central Neuropathic Pain
Central Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT03901352 ↗Enrolled (actual)
300
Serious AEs
8.6%
Results posted
Sep 2024
Primary outcome: Primary: Change From Baseline in the Weekly Average Daily Pain Score (ADPS) at Week 14 Following Administration With Mirogabalin or Placebo — -1.23; -0.52 units on a scale — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Mirogabalin (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Weekly Average Daily Pain Score (ADPS) at Week 14 Following Administration With Mirogabalin or Placebo |
-1.23; -0.52 | 0.0001 sig |
| SECONDARY Number of Participants With ≥30% Reduction and ≥50% Reductions From Baseline in Average Daily Pain Score (ADPS) |
46; 28; 21; 9 | — |
| SECONDARY Change From Baseline in Present Pain Intensity on the Short Form-McGill Pain Questionnaire at Week 14 Following Administration With Mirogabalin or Placebo |
-0.6; -0.3 | — |
| SECONDARY Patient Global Impression of Change at Week 14 Following Administration With Mirogabalin or Placebo |
26; 11; 80; 53 | — |
| SECONDARY Change From Baseline in the Weekly Average Daily Sleep Interference Score (ADSIS) Following Administration With Mirogabalin or Placebo |
-1.14; -0.35 | — |
| SECONDARY Change From Baseline in the Medical Outcomes Study Sleep Scale Scores Following Administration With Mirogabalin or Placebo |
4.23; 1.27; -1.12; 0.61; 2.04; 0.71 | — |
| SECONDARY Change From Baseline in the Hospital Anxiety & Depression Scale Following Administration With Mirogabalin or Placebo |
-0.8; -0.7; -1.0; -0.8 | — |
| SECONDARY Change From Baseline in the Neuropathic Pain Symptom Inventory Score Following Administration With Mirogabalin or Placebo |
-4.2; -1.5; -2.5; -0.9; -2.6; -1.0 | — |
| SECONDARY Change From Baseline in the EuroQoL 5 Dimensions 5 Levels Following Administration With Mirogabalin or Placebo |
0.0395; 0.0153; 4.9; -1.8 | — |
| SECONDARY Change From Baseline in the Spinal Cord Independence Measure Scores Following Administration With Mirogabalin or Placebo |
0.3; 0; 0.7; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Performed At Level or Below Level for Allodynia Following Administration With Mirogabalin or Placebo |
10; 13; 5; 6 | — |
| SECONDARY Change From Baseline in Present Pain Intensity on the Short Form-McGill Pain Questionnaire at Week 52 Following Administration With Mirogabalin During the Long-term Extension (LTE) |
-9.6 | — |
Summary
Investigate the efficacy and safety of mirogabalin in participants with central neuropathic pain in comparison to placebo
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03901352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.