Status:
ACTIVE_NOT_RECRUITING
Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia
Lead Sponsor:
Shanghai SIMR Biotechnology Co., Ltd.
Conditions:
Trigeminal Neuralgia
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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...
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-tre...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of trigeminal neuralgia as per International Classification of Headache Disorders third version (ICHD-3) criteria
- Subjects must have completed at least 5 daily pain score and experienced ≥3 paroxysms per day with a daily average pain sore of ≥4 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
- 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
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06571448
Start Date
September 16 2024
End Date
February 1 2026
Last Update
December 31 2025
Active Locations (1)
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1
China-Japan Friendship Hospital
Beijing, China