A Study of ONO-1110 in Patients With Postherpetic Neuralgia

A Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Trial to Evaluate the Efficacy and Safety of ONO-1110 in Patients With Postherpetic Neuralgia

To evaluate the efficacy and safety of ONO-1110 in Japanese patients with postherpetic neuralgia

Study Overview

• Status: Active, not recruiting
• Conditions: Postherpetic Neuralgia
• Intervention / Treatment: Drug: Placebo; Drug: ONO-1110

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan
    • Kamezawa Clinic
  • Aichi, Japan
    • Kimura Clinic
  • Fukuoka, Japan
    • Fukuoka Tokushukai Hospital
  • Fukushima, Japan
    • Southern Tohoku General Hospital
  • Gifu, Japan
    • Central Japan International Medical Center
  • Hiroshima, Japan
    • National Hospital Organization Kure Medical Center
  • Hokkaido, Japan
    • National Hospital Organization Hokkaido Medical Center
  • Hyōgo, Japan
    • Nishinomiya Municipal Central Hospital
  • Ibaraki, Japan
    • Mito Saiseikai General Hospital
  • Kanagawa, Japan
    • Kawasaki Municipal Hospital
  • Kanagawa, Japan
    • Konan Hidamari Pain Clinic
  • Kanagawa, Japan
    • Nomura Dermatology Clinic
  • Kanagawa, Japan
    • Tai Clinic
  • Kanagawa, Japan
    • Yokohama City Minato Red Cross Hospital
  • Miyazaki, Japan
    • Junwakai Memorial Hospital
  • Miyazaki, Japan
    • Medical Corporation Toyama Dermatology
  • Okinawa, Japan
    • Yuaikai Tomishiro Chuo Hospital
  • Osaka, Japan
    • Osaka Metropolitan University Hospital
  • Osaka, Japan
    • Morimoto Clinic
  • Osaka, Japan
    • Osaka Medical and Pharmaceutical University Hospital
  • Shizuoka, Japan
    • Chutoen General Medical Center
  • Shizuoka, Japan
    • Shizuoka Rehabili Pain Clinic
  • Tokyo, Japan
    • Juntendo University Hospital
  • Tokyo, Japan
    • Tokyo-Eki Center-building Clinic
  • Tokyo, Japan
    • Fukuwa Clinic
  • Tokyo, Japan
    • Fukuuchi Pain Clinic
  • Tokyo, Japan
    • Futaki Skin Care Clinic
  • Tokyo, Japan
    • Mitaka Pain Clinic
  • Tokyo, Japan
    • Nishiogi Pain Clinic
  • Yamanashi, Japan
    • Yamanashi Prefectural Central Hospital
  • Ōita, Japan
    • Medical Corporation Fujigaki Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Japanese (both sexes)
• Age (at the time of informed consent): 18 years and older
• Outpatient
• Patients with persistent pain ≥3 months (90 days) after the onset of herpes zoster
• Patients who are considered capable of understanding the study procedures and completing the pain diary and questionnaires appropriately by the investigator (sub-investigator)

Exclusion Criteria:

• Patients who previously underwent neurodestruction or neurosurgical therapy for PHN
• Patients with pain other than PHN that may affect assessments in this study
• Patients with any skin condition related to the site of herpes zoster that may affect assessments in this study
• Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study
• Patients with concurrent psychiatric diseases that may affect assessments in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo tablets once daily	Drug: Placebo; Placebo tablets once daily
Experimental: ONO-1110; ONO-1110 tablets once a day	Drug: ONO-1110; ONO-1110 tablets once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in weekly mean of average pain score (last 7-day mean of past 24-hour average pain scores [NRS] in the pain diary) from baseline to Week 8 of the treatment period	Up to 15 weeks
Adverse Events	Up to 15 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in weekly mean of average pain score from baseline to each week	Up to 15 weeks
30%- and 50%-responder rates based on the weekly mean of average pain score (proportions of participants whose weekly mean of average pain score has decreased by 30% and 50% from baseline, respectively)	Up to 15 weeks
Change in weekly mean of worst pain score (last 7-day mean of past 24-hour worst pain scores [NRS] in the pain diary) from baseline to each week	Up to 15 weeks
30%- and 50%-responder rates based on the weekly mean of worst pain score (proportions of participants whose weekly mean of worst pain score has decreased by 30% and 50% from baseline, respectively)	Up to 15 weeks
Change in Brief pain inventory-short form (BPI-SF) score from baseline	Up to 15 weeks
Change in Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) score from baseline	Up to 15 weeks
Patient Global Impression of Change (PGIC) score	Up to 15 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score from baseline	Up to 15 weeks
Plasma ONO-1110 concentrations	Up to 15 weeks

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: November 24, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: PHN; Postherpetic Neuralgia; ONO-1110; ONO-1110-04
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuralgia, Postherpetic
• Other Study ID Numbers: ONO-1110-04; jRCT2031240504 (Registry Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No