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

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.

Study Overview

• Status: Completed
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Drug: Placebo; Drug: SR750 tablet; Drug: SR750 tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Diagnosis of trigeminal neuralgia as per International Classification of Headache Disorders third version (ICHD-3) criteria
• Subjects must have experienced ≥3 paroxysms per day with a daily average pain sore of ≥4 and ≤8 on PI-NRS during the five days prior to randomization.
• Willing and able to undergo washout of prohibited medication as per protocol requirements and refrain from use of the prohibited medication throughout the study period.
• Female subjects must be non-pregnant and non-lactating.

Key Exclusion Criteria:

• Secondary trigeminal neuralgia
• Painful trigeminal neuropathies
• Other pains that cannot be clearly differentiated from the pain associated with TN or may interfere with the pain assessment
• Subjects have previously undergone microvascular decompression (MVD), sensory rhizotomy of trigeminal nerve, radiofrequency ablation (RFA), percutaneous balloon compression (PBC), permanent lesion of trigeminal semilunar ganglion, botulinum toxin type A for the treatment of TN within 6 months prior to screening. Subjects with severe complication after therapeutic procedure would also be excluded.
• Known history of human immunodeficiency virus (HIV) or active infection of hepatitis B virus (HBV), hepatitis C virus (HCV) or Treponema Pallidum

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: SR750 high dose	Drug: SR750 tablet; SR750 high dose BID orally for 6 weeks; Drug: SR750 tablet; SR750 low dose BID orally for 6 weeks
Experimental: SR750 low dose	Drug: SR750 tablet; SR750 high dose BID orally for 6 weeks; Drug: SR750 tablet; SR750 low dose BID orally for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Average Pain Score (DAPS)	Change from baseline to week 6 in the weekly average of the daily average pain score (DAPS) of paroxysms using pain intensity numerical rating scale (PI-NRS).The PI-NRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.	up to week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of responders	Proportion of subjects who meets one of the following criteria,; Patient Global Impression of Change (PGIC) response of "Much Improved" or "Very Much Improved" at Week 6. Subjects will select a value to represent their overall status since the start of the study on a 7-point scale of PGIC on which 1 corresponds to "very much improved", 2 corresponds to "much improved", 3 corresponds to "slightly improved" 4 corresponds to "no change", 5 corresponds to "slightly worse", 6 corresponds to "much worse", and 7 corresponds to "very much worse".; A reduction of ≥2 points from baseline in mean pain score at Week 6; A reduction of ≥30% from baseline in mean pain score at Week 6; A reduction of ≥50% from baseline in mean pain score at Week 6; A reduction of ≥30% from baseline in mean number of paroxysms at Week 6; A reduction of ≥50% from baseline in mean number of paroxysms at Week 6; A reduction of ≥30% from baseline in mean worst pain score at Week 6	up to week 6
Mean number of paroxysms by week	Change from baseline in mean number of paroxysms by week	up to week 6
Proportion of subjects with continuous pain at week 6	Change of proportion from baseline	up to week 6
Hospital Anxiety and Depression Scale (HADS)	Change of HADS from baseline. The HADS is a self-administered questionnaire consisting of two subscales, one for anxiety (HADS-A Subscale) and the other for depression (HADS-D Subscale). Each subscale consists of 7 items, and subjects will rate each item as it applies to them 0 points = absence of anxiety or depression; 3 points = severe anxiety or depression. The HADS-A Subscale analyzes generalized anxiety states, including anxious feelings, restlessness, anxious thoughts, and panic attacks. The HADS-D Subscale focuses on states of loss of interest and reduced pleasure response (reduced enjoyment mood). Each subscale will receive a score from 0 to 21, with bigger number indicating more severe symptom.	up to week 6
Use of rescue medication	Including the first time to use rescue medication, total amount and proportion	up to week 7
Mean pain score by week	Change from baseline in weekly mean pain score. The daily pain score will be measured by PI-NRS described as above.	up to week 6
Mean worst pain score by week	Change from baseline in mean worst pain score by week. The daily worst pain score will be measured by PI-NRS described as above.	up to week 6
Mean continuous pain score by week	Change from baseline in mean continuous pain score by week. The daily continuous pain score will be measured by PI-NRS described as above.	up to week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	To collect the adverse events during the study	up to week 7
Plasma concentration of SR750 and its metabolite	To measure the plasma concentration of SR750 and its metabolite after dosing	up to day 43

Collaborators and Investigators

• Sponsor: Shanghai SIMR Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Bifa Fan, MD, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Actual): January 26, 2026
• Study Completion (Actual): February 24, 2026

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Trigeminal Neuralgia; SR750
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Cranial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Trigeminal Neuralgia
• Other Study ID Numbers: SR750-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No