DS-5565 Phase III Study for Post-herpetic Neuralgia

NCT02318719 | Completed Results

• 1 other identifier: DS5565-A-J304
• Study Type: interventional
• Target: 765
• Locations: 1 country
• Sites: 1

Brief Summary

Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia (PHN) in comparison to placebo

Conditions

Post-Herpetic Neuralgia

Keywords

Post-Herpetic Neuralgia; Developmental Phase III

Outcome Measures

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.

  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

  From baseline (Week 14) to Week 66

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo (14-weeks)

Drug: Placebo

DS-5565 15 mg Group

EXPERIMENTAL

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

Drug: DS-5565

DS-5565 20 mg Group

EXPERIMENTAL

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

Drug: DS-5565

DS-5565 30 mg Group

EXPERIMENTAL

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

Drug: DS-5565

Interventions

Placebo DRUG

Placebo

Placebo

DS-5565 DRUG

Also known as: Mirogabalin

DS-5565 15 mg Group; DS-5565 20 mg Group; DS-5565 30 mg Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PHN defined as pain present for more than 3 months after herpes zoster skin rash at screening
• At screening, a pain scale of ≥ 40 mm

You may not qualify if:

• Previous use of neurolytic block

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead
• SRL Medisearch Inc.: collaborator
• Quintiles, Inc.: collaborator

Study Sites (1)

Medical Corporation Fujigaki Clinic

Ōita, 870-0942, Japan

Location

Related Publications (2)

• 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.

  PMID: 34059327 DERIVED

• 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.

  PMID: 32899037 DERIVED

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

mirogabalin

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daichii Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 17, 2014
• Study Start: January 1, 2015
• Primary Completion: May 25, 2017
• Study Completion: May 25, 2017
• Last Updated: November 2, 2020
• Results First Posted: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

JP (1)