A Study of ONO-1110 in Patients With Postherpetic Neuralgia

Phase 2

Recruiting

• Conditions: Postherpetic Neuralgia
• Interventions: Drug: ONO-1110; Drug: Placebo

• Registration Number: NCT06708416
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-24
• Study First Posted: 2024-11-27
• Status Verified: 2025-02
• Study Start: 2025-02-12
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-06-30
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONO-1110	ONO-1110	ONO-1110 tablets once a day
Placebo	Placebo	Placebo tablets once daily

Primary Outcome Measures

Name	Time	Method
Adverse Events	Up to 15 weeks
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical Corporation Fujigaki Clinic; 🇯🇵 Ōita, Japan