Clinical Research Directory

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