Clinical trial NCT06708416: A Study of ONO-1110 in 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Keywords: ONO-1110
ONO-1110-04
Postherpetic Neuralgia
PHN
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-11-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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
timeFrame: Up to 15 weeks
measure: Adverse Events
timeFrame: Up to 15 weeks
Secondary outcomes:
measure: Change in weekly mean of average pain score from baseline to each week
timeFrame: Up to 15 weeks
measure: 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)
timeFrame: Up to 15 weeks
measure: 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
timeFrame: Up to 15 weeks
measure: 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)
timeFrame: Up to 15 weeks
measure: Change in Brief pain inventory-short form (BPI-SF) score from baseline
timeFrame: Up to 15 weeks
measure: Change in Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) score from baseline
timeFrame: Up to 15 weeks
measure: Patient Global Impression of Change (PGIC) score
timeFrame: Up to 15 weeks
measure: Change in Hospital Anxiety and Depression Scale (HADS) score from baseline
timeFrame: Up to 15 weeks
measure: Plasma ONO-1110 concentrations
timeFrame: Up to 15 weeks
Other outcomes:
Locations:
city: Ōita
country: Japan
facility: Medical Corporation Fujigaki Clinic
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: