DS-5565 Phase III Study for Post-herpetic Neuralgia

Browse trials for

• Neuralgia 1,287
• Neuralgia, Postherpetic 195

Keywords

• Post-Herpetic Neuralgia
• Developmental Phase III

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 765 is above the median of 52 across 973 interventional studies indexed under Neuralgia.

Lead sponsor

Daiichi Sankyo Co., Ltd. is the lead sponsor of 72 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.

Study arms

• Placebo comparator
  Placebo

  Placebo (14-weeks)

  Drug: Placebo

• Experimental
  DS-5565 15 mg Group

  DS-5565 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose

  Drug: DS-5565

• Experimental
  DS-5565 20 mg Group

  DS-5565 20 mg, oral administration, Treatment period; 1-week titration and 13-weeks fixed dose

  Drug: DS-5565

• Experimental
  DS-5565 30 mg Group

  DS-5565 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose

  Drug: DS-5565

Interventions

• DrugPlacebo

  Placebo

• DrugDS-5565

  Also known as: Mirogabalin

Primary outcomes

1. Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia

   Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary). In this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain.

   Time frame: Baseline to Week 14

Secondary outcomes

1. Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia

   Visual Analog Scale (VAS) pain is a 10-point assessment tool to measure pain levels, where 0 is defined as 'no pain' and 10 is defined as 'worst possible pain'. Higher VAS pain scores indicate worse outcome. In this outcome, the change from baseline in VAS pain is being reported with negative values representing improvements in pain intensity. The larger the negative value (ie. improvement), the greater the improvement in pain intensity.

   Time frame: From baseline (Week 14) to Week 66

Baseline characteristics

Publications

• Kato J, Baba M, Kuroha M, Kakehi Y, Murayama E, Wasaki Y, Ohwada S. Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies. Clin Ther. 2021 May;43(5):822-835.e16. doi: 10.1016/j.clinthera.2021.03.015. Epub 2021 May 29. PubMed 34059327 ↗
• Kato J, Matsui N, Kakehi Y, Murayama E, Ohwada S. Long-term safety and efficacy of mirogabalin in Asian patients with postherpetic neuralgia: Results from an open-label extension of a multicenter randomized, double-blind, placebo-controlled trial. Medicine (Baltimore). 2020 Sep 4;99(36):e21976. doi: 10.1097/MD.0000000000021976. PubMed 32899037 ↗

Study documents

• Protocol and statistical analysis plan · Apr 18, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting information: Study protocol, Sap, Csr