NCT06571448

Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia

A Phase 2 Randomized, Double-blind and Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Shanghai SIMR Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy，safety and tolerability of SR750 in patients with trigeminal neuralgia (TN). Patients will receive SR750 (study drug) or placebo for 6 weeks and keep a diary of daily pain. The study duration for each patient is up to 11 weeks.

Detailed description

This is a phase 2, randomized, double-blind study comparing SR750 with placebo in patients with trigeminal neuralgia. It consists of a screening period, a double-blind treatment period, and a post-treatment safety follow-up period. Baseline pain intensity and number of paroxysms will be taken in the run-in period of screening period and will be checked for eligibility. Around 162 eligible subjects will be recruited and randomized into three arms at 1:1:1 ratio to receive SR750 high dose twice a day (BID) , SR750 low dose BID or placebo BID for 6 weeks. Subjects, investigators, all clinical study site staffs, and the Sponsor will remain blinded to treatment assignment during the study. Subjects will be asked to record the number of paroxysms of pain, severity of daily average pain of paroxysms and severity of daily worst pain in e-diary over the last 24 hours every night before going to bed. After completion of double-blind period, subjects will continue to complete the safety follow-up.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
DRUG	SR750 tablet	SR750 high dose BID orally for 6 weeks
DRUG	SR750 tablet	SR750 low dose BID orally for 6 weeks
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-09-16
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2024-08-26
• Last updated: 2025-12-31

Locations

1 site across 1 country: China