MOTION-OA 301 — Study Synopsis

Demo Status: Simulated clinical trial created for demonstration purposes only.

Full Study Title: MOTION-OA 301: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating an Investigational Non-Opioid Therapy in Adults with Symptomatic Osteoarthritis of the Knee or Hip Using Conversational AI, WOMAC Assessment, and Voice-Based Sentiment Analysis

Protocol Number: MOTION-OA-301

Sponsor: Northstar Therapeutics — Demo Sponsor

Phase: Phase 3

Therapeutic Area: Musculoskeletal / Rheumatology

Indication: Symptomatic Osteoarthritis of the Knee or Hip

Study Status: Active — Recruiting

Principal Investigator: Dr. Elena Martinez, MD — Demo Investigator

Planned Enrollment: 600 participants

Number of Sites: 30 U.S. clinical research sites

Study Duration per Participant: 24 weeks

Randomization: 1:1

Blinding: Double-blind

Control: Placebo-controlled

Investigational Product: NST-401 — fictional investigational non-opioid oral therapy

Study Design

MOTION-OA 301 is a prospective, multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of NST-401 compared with placebo in adults with symptomatic osteoarthritis of the knee or hip. Approximately 600 participants will be randomized 1:1 to receive NST-401 or matching placebo for 24 weeks.

Each participant will have one qualifying index joint designated at baseline. The index joint may be the right knee, left knee, right hip, or left hip and will remain the target joint for efficacy assessments throughout the study.

Patient-reported outcomes will be collected electronically at scheduled study visits. The WOMAC assessment will be administered through a protocol-configured conversational AI agent. Voice-derived sentiment and affective signals will be analyzed using Hume AI as an additional contextual signal during assessment administration.

Primary Endpoints (Co-Primary, Week 12)

1. Change from baseline in WOMAC Pain score for the designated index knee or hip
2. Change from baseline in WOMAC Physical Function score for the designated index knee or hip

Secondary Endpoints

• Change from baseline in WOMAC Stiffness score
• Change from baseline in overall WOMAC score
• Proportion of participants achieving a clinically meaningful improvement in pain
• Patient Global Impression of Change
• Change in participant-reported index-joint pain
• Change in mobility and activity limitation
• Rescue analgesic use
• Treatment satisfaction
• Health-related quality of life
• Incidence of treatment-emergent adverse events
• Treatment discontinuations due to adverse events

Exploratory Digital Endpoints

The study will also evaluate conversational and voice-derived measures associated with electronic clinical outcome assessment administration, including sentiment associated with individual responses, changes in affective expression across visits, hesitation/uncertainty signals, clarification requests, response-content and vocal-expression dissonance, Intervention Agent activation, and assessment completion metrics. These exploratory measures are not used to override the participant's reported WOMAC answer.

Demo Participant Configuration

• Participant ID: MOT-301-0147
• Participant Name: Demo Participant
• Study Arm: Blinded
• Current Visit: Week 12
• Study Day: Day 84
• Index Joint: Right Hip
• Condition: Symptomatic Right Hip Osteoarthritis
• Assigned Assessment: WOMAC Hip
• Assessment Method: Conversational AI with Voice Sentiment Analysis
• Assessment Status: Due Today
• Sentiment Analysis: Enabled (Hume AI)
• Intervention Agent: Enabled
• Previous Assessment: Week 8 — Completed
• Next Assessment: Week 24