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

Ono Pharmaceutical Co. Ltd28 sites in 1 country140 target enrollmentFebruary 12, 2025

InterventionsONO-1110 Placebo

DrugsONO-1110 Placebo

Overview

Phase: Phase 2
Intervention: ONO-1110
Conditions: Not specified
Sponsor: Ono Pharmaceutical Co. Ltd
Enrollment: 140
Locations: 28
Primary Endpoint: 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
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 12, 2025

End Date

August 31, 2026

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ono Pharmaceutical Co. Ltd

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

ONO-1110

ONO-1110 tablets once a day

Intervention: ONO-1110

Placebo

Placebo tablets once daily

Intervention: Placebo

Outcomes

Primary Outcomes

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

Adverse Events

Time Frame: Up to 15 weeks

Secondary Outcomes

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)