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

SIMR Biotech

Status and phase: Active, not recruiting; Phase 2

Conditions: Trigeminal Neuralgia

Treatments: Drug: SR750 tablet; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06571448

SR750-202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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138 participants in 3 patient groups, including a placebo group

SR750 high dose

Experimental group

Treatment:

Drug: SR750 tablet

Drug: SR750 tablet

SR750 low dose

Experimental group

Treatment:

Drug: SR750 tablet

Drug: SR750 tablet

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo