Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia
NCT Number: NCT06571448
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Trigeminal Neuralgia
Interventions: DRUG: SR750 tablet|DRUG: SR750 tablet|DRUG: Placebo
Sponsor: Shanghai SIMR Biotechnology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 162
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-11

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.

Primary Outcome Measures: 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: 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 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 number of paroxysms by week, Change from baseline in mean number of paroxysms by week, 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|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
Other Outcome Measures: 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