A Clinical Study of ONO-1110 in Patients With Fibromyalgia

Phase 2

Recruiting

• Conditions: Fibromyalgia
• Interventions: Drug: ONO-1110; Drug: Placebo

• Registration Number: NCT06752590
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2024-12-22
• Study First Posted: 2024-12-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Study Start: 2025-03
• Primary Completion: 2026-07
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Japanese (both sexes)
• Outpatient
• 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 meet the American College of Rheumatology Fibromyalgia Criteria

Exclusion Criteria

• Patients with inflammatory arthritis, infectious arthritis, or autoimmune disease
• Patients with pain other than FM 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 a past history of or concurrent malignant tumor within 3 years
• Patients who are pregnant, nursing, or possibly pregnant, or intending to become pregnant during the study period.

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
Change in weekly mean of average pain score from baseline to Week 8 of the treatment period	Up to 16 weeks
Adverse events	Up to 16 weeks

Secondary Outcome Measures

Name	Time	Method
Change in weekly mean of average pain score from baseline in each week	Up to 16 weeks
30%- and 50%-responder rates based on the weekly mean of average pain score	Up to 16 weeks	proportions of participants whose weekly mean of average pain score has decreased by 30% and 50% from baseline, respectively
Change in weekly mean of worst pain score from baseline to each week	Up to 16 weeks
30%- and 50%-responder rates based on the weekly mean of worst pain score	Up to 16 weeks	proportions of participants whose weekly mean of worst pain score has decreased by 30% and 50% from baseline, respectively
Change in WPI and SSS score of 2016 Revised FM Diagnostic Criteria by ACR from baseline	Up to 16 weeks
Change in Japanese version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) score from baseline	Up to 16 weeks
Change in Patient Global Impression of Change (PGIC) score from baseline	Up to 16 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score from baseline	Up to 16 weeks
Change in Medical Outcomes Study Sleep Scale (MOS-Sleep Scale) score from baseline	Up to 16 weeks
Plasma ONO-1110 concentrations	Up to 16 weeks

Trial Locations

Locations (20)

Kimura Clinic; 🇯🇵 Nagoya, Aichi, Japan

Ginza Neurological Clinic; 🇯🇵 Tokyo, Japan

National Hospital Organization Shimoshizu National Hospital; 🇯🇵 Yotsukaidō, Chiba, Japan

Sapporo City General Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Shirasawa Orthopedic Clinic; 🇯🇵 Morioka, Iwate, Japan

Miyashita Rheumatology Clinic; 🇯🇵 Ōmura, Nagasaki, Japan

Medical Corporation Fujigaki Clinic; 🇯🇵 Ōita, Oita, Japan

Ai Sakura Clinic; 🇯🇵 Fukuoka, Japan

Morimoto Clinic; 🇯🇵 Osaka, Japan

Shizuoka Rehab Pain Clinic; 🇯🇵 Shizuoka, Japan

Fukuwa Clinic; 🇯🇵 Tokyo, Japan

Sanno Hospital; 🇯🇵 Tokyo, Japan

Tokyo-Eki Center-Building Clinic; 🇯🇵 Tokyo, Japan

Kokorotoitami Clinic; 🇯🇵 Kawasaki, Kanagawa, Japan

Japanese Red Cross Okayama Hospital; 🇯🇵 Okayama, Japan

Hayaishi Hospital; 🇯🇵 Osaka, Japan

Himenotomomi Clinic; 🇯🇵 Tokyo, Japan

Juntendo University Nerima Hospital; 🇯🇵 Tokyo, Japan

Nihonbashi Medical; 🇯🇵 Tokyo, Japan

Juntendo Tokyo Koto Geriatric Medical Center; 🇯🇵 Tokyo, Japan