Back to resultsDS-5565 Phase III Study for Post-herpetic Neuralgia
Primary Purpose
Post-Herpetic Neuralgia
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Placebo
DS-5565
Sponsored by
About this trial
This is an interventional treatment trial for Post-Herpetic Neuralgia focused on measuring Post-Herpetic Neuralgia, Developmental Phase III
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous use of neurolytic block
Sites / Locations
- Medical Corporation Fujigaki Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
DS-5565 15 mg Group
DS-5565 20 mg Group
DS-5565 30 mg Group
Arm Description
Placebo (14-weeks)
DS-5565 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
DS-5565 20 mg, oral administration, Treatment period; 1-week titration and 13-weeks fixed dose
DS-5565 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02318719
First Posted
December 11, 2014
Last Updated
October 29, 2020
Sponsor
Daiichi Sankyo Co., Ltd.
Collaborators
SRL Medisearch Inc., Quintiles, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02318719
Brief Title
DS-5565 Phase III Study for Post-herpetic Neuralgia
Official Title
An Asian, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled 14-Week Study of DS-5565 in Patients With Post-herpetic Neuralgia Followed by a 52-Week Open-label Extension
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
May 25, 2017 (Actual)
Study Completion Date
May 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.
Collaborators
SRL Medisearch Inc., Quintiles, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia (PHN) in comparison to placebo
Detailed 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 subjects with PHN receiving DS-5565 versus placebo.
[Open Extension Phase] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with PHN.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Herpetic Neuralgia
Keywords
Post-Herpetic Neuralgia, Developmental Phase III
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
765 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (14-weeks)
Arm Title
DS-5565 15 mg Group
Arm Type
Experimental
Arm Description
DS-5565 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
Arm Title
DS-5565 20 mg Group
Arm Type
Experimental
Arm Description
DS-5565 20 mg, oral administration, Treatment period; 1-week titration and 13-weeks fixed dose
Arm Title
DS-5565 30 mg Group
Arm Type
Experimental
Arm Description
DS-5565 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
DS-5565
Other Intervention Name(s)
Mirogabalin
Primary Outcome Measure Information:
Title
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
Description
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 Outcome Measure Information:
Title
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
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Previous use of neurolytic block
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daichii Sankyo
Official's Role
Study Director
Facility Information:
Facility Name
Medical Corporation Fujigaki Clinic
City
Oita
ZIP/Postal Code
870-0942
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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/
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
34059327
Citation
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.
Results Reference
derived
PubMed Identifier
32899037
Citation
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.
Results Reference
derived
Learn more about this trial
DS-5565 Phase III Study for Post-herpetic Neuralgia
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