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Clinical Trial NCT06708416 for Postherpetic Neuralgia is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study of ONO-1110 in Patients With Postherpetic Neuralgia Phase 2 140

Active, not recruiting
Clinical Trial NCT06708416 is designed to study Treatment for Postherpetic Neuralgia. It is a Phase 2 interventional study that is active, not recruiting, having started on 12 February 2025, with plans to enroll 140 participants. Led by Ono Pharmaceutical Co. Ltd, it is expected to complete by 31 August 2026. The latest data from ClinicalTrials.gov was last updated on 2 March 2026.
Brief Summary
To evaluate the efficacy and safety of ONO-1110 in Japanese patients with postherpetic neuralgia
Official Title

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

Conditions
Postherpetic Neuralgia
Other Study IDs
  • ONO-1110-04
  • jRCT2031240504 (Registry Identifier) (Japan Registry of Clinical Trials)
NCT ID Number
NCT06708416
Start Date (Actual)
2025-02-12
Last Update Posted
2026-03-02
Completion Date (Estimated)
2026-08-31
Enrollment (Estimated)
140
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
ONO-1110
ONO-1110-04
Postherpetic Neuralgia
PHN
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalONO-1110
ONO-1110 tablets once a day
ONO-1110
ONO-1110 tablets once a day
Placebo ComparatorPlacebo
Placebo tablets once daily
Placebo
Placebo tablets once daily
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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)

  • 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
Ono Pharmaceutical Co. Ltd logoOno Pharmaceutical Co. Ltd62 active studies to explore
No contact data.
31 Study Locations in 1 Countries
Kamezawa Clinic, Aichi, Japan
Kimura Clinic, Aichi, Japan
Fukuoka Tokushukai Hospital, Fukuoka, Japan
Southern Tohoku General Hospital, Fukushima, Japan
Central Japan International Medical Center, Gifu, Japan
National Hospital Organization Kure Medical Center, Hiroshima, Japan
National Hospital Organization Hokkaido Medical Center, Hokkaido, Japan
Nishinomiya Municipal Central Hospital, Hyōgo, Japan
Mito Saiseikai General Hospital, Ibaraki, 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, Kanagawa, Japan
Junwakai Memorial Hospital, Miyazaki, Japan
Medical Corporation Toyama Dermatology, Miyazaki, Japan
Yuaikai Tomishiro Chuo Hospital, Okinawa, Japan
Morimoto Clinic, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital, Osaka, Japan
Osaka Metropolitan University Hospital, Osaka, Japan
Medical Corporation Fujigaki Clinic, Ōita, Japan
Chutoen General Medical Center, Shizuoka, Japan
Shizuoka Rehabili Pain Clinic, Shizuoka, Japan
Fukuuchi Pain Clinic, Tokyo, Japan
Fukuwa Clinic, Tokyo, Japan
Futaki Skin Care Clinic, Tokyo, Japan
Juntendo University Hospital, Tokyo, Japan
Mitaka Pain Clinic, Tokyo, Japan
Nishiogi Pain Clinic, Tokyo, Japan
Tokyo-Eki Center-Building Clinic, Tokyo, Japan
Yamanashi Prefectural Central Hospital, Yamanashi, Japan