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

NCT06571448 | Completed Phase 2

• 1 other identifier: SR750-202
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trigeminal Neuralgia

Keywords

Trigeminal Neuralgia; SR750

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Proportion of responders

  up to week 6

• Mean pain score by week

  up to week 6

• Mean worst pain score by week

  up to week 6

• Mean number of paroxysms by week

  up to week 6

• Mean continuous pain score by week

  up to week 6

Other Outcomes (2)

• Adverse events

  up to week 7

• Plasma concentration of SR750 and its metabolite

  up to day 43

Study Arms (3)

SR750 high dose

EXPERIMENTAL

Drug: SR750 tablet

SR750 low dose

EXPERIMENTAL

Drug: SR750 tablet

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SR750 tablet DRUG

SR750 high dose BID orally for 6 weeks

SR750 high dose

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai SIMR Biotechnology Co., Ltd.: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Bifa Fan, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: September 16, 2024
• Primary Completion: January 26, 2026
• Study Completion: February 24, 2026
• Last Updated: April 24, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)