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DS-5565 Phase III Study for Post-herpetic Neuralgia

This study has been completed.
Sponsor:
Collaborators:
SRL Medisearch Inc.
Quintiles, Inc.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT02318719
First received: December 11, 2014
Last updated: June 14, 2017
Last verified: June 2017
  Purpose
Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia (PHN) in comparison to placebo

Condition Intervention
Post-Herpetic Neuralgia Drug: Placebo Drug: DS-5565

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):

Primary Outcome Measures:
  • Change in the Average Daily Pain Score (ADPS) [ Time Frame: baseline to week 14 ]
    Change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian subjects with PHN receiving DS-5565 versus placebo


Enrollment: 765
Actual Study Start Date: January 2015
Study Completion Date: May 25, 2017
Primary Completion Date: May 25, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo (14-weeks)
Drug: Placebo
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
Other Name: Mirogabalin
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
Other Name: Mirogabalin
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
Other Name: Mirogabalin

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.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02318719

Locations
Japan
Medical Corporation Fujigaki Clinic
Oita, Japan, 870-0942
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
SRL Medisearch Inc.
Quintiles, Inc.
Investigators
Study Director: Global Clinical Leader Daichii Sankyo
  More Information

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02318719     History of Changes
Other Study ID Numbers: DS5565-A-J304
Study First Received: December 11, 2014
Last Updated: June 14, 2017

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Post-Herpetic Neuralgia
Developmental Phase III

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 17, 2017