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Completed

NCT Number: NCT06708416

A Study of ONO-1110 in Patients With Postherpetic Neuralgia

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kamezawa Clinic, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-1110

Drug

ONO-1110 tablets once a day

Placebo

Drug

Placebo tablets once daily

Primary outcomes

  1. 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

    Time frame: Up to 15 weeks

  2. Adverse Events

    Time frame: Up to 15 weeks

Secondary outcomes

  1. Change in weekly mean of average pain score from baseline to each week

    Time frame: Up to 15 weeks

  2. 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)

    Time frame: Up to 15 weeks

  3. 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

    Time frame: Up to 15 weeks

  4. 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)

    Time frame: Up to 15 weeks

  5. Change in Brief pain inventory-short form (BPI-SF) score from baseline

    Time frame: Up to 15 weeks

  6. Change in Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) score from baseline

    Time frame: Up to 15 weeks

  7. Patient Global Impression of Change (PGIC) score

    Time frame: Up to 15 weeks

  8. Change in Hospital Anxiety and Depression Scale (HADS) score from baseline

    Time frame: Up to 15 weeks

  9. Plasma ONO-1110 concentrations

    Time frame: Up to 15 weeks

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 27, 2024
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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