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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SR750 high dose | Experimental |
| |
| SR750 low dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR750 tablet | Drug | SR750 high dose BID orally for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders | Proportion of subjects who meets one of the following criteria,
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bifa Fan, MD | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| SR750 tablet |
| Drug |
SR750 low dose BID orally for 6 weeks |
|
| Placebo | Drug | Placebo |
|
| 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 |
| up to day 43 |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |