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A Phase III Confirmatory Trial of NPC-06 in Patients with Acute Exacerbation of Trigeminal Neuralgia.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Trigeminal neuralgia
Date of first enrollment	20/01/2026
Target sample size	34
Countries of recruitment
Study type	Interventional
Intervention(s)	(NPC-06)(Placebo) 1.Initial dose (Day 1) <Dose> An 18 mg/kg of the test drug or placebo will be injected by intravenous drip infusion once daily. The maximum dose of the test drug should not exceed 1,200 mg as fosphenytoin sodium. <Administration method> Dilute the study drug 3 to 4-fold using physiological saline for intravenous infusion and then administer the solution over 18 minutes and less than 30 minutes. 2.Maintenance dose(Day 2-5) <Dose> A 7.5 mg/kg of the test drug or placebo will be injected as needed by intravenous drip infusion once daily. The maximum dose of the test drug should not exceed 525 mg as fosphenytoin sodium. <Administration method> Dilute the study drug 3-to 4-fold using physiological saline for intravenous infusion and then administer the solution over 7 minutes and 30 seconds and less than 20 minutes.

Outcome(s)

Primary Outcome

Change from baseline in the mean NRS score at 60, 90, and 120 minutes after initiation of the first administration of the investigational product.

Secondary Outcome

1) Change from baseline in the NRS score at 120 minutes after initiation of the first administration of the investigational product. 2) Change from baseline in the NRS score at 120 minutes after initiation of the first maintenance dose of the investigational product. 3) Trajectory of change from baseline in the NRS score from initiation of the first administration of the investigational product to immediately before administration of the second maintenance dose. 4) Trajectory of change in the NRS score from immediately before administration of the first maintenance dose to immediately before administration of the second maintenance dose. 5) Area under the curve (AUC) of the 24-hour-normalized NRS score from immediately before initiation of the first administration of the investigational product to immediately before administration of the first maintenance dose. 6) Total number of trigeminal neuralgia attacks (per 24 hours) from immediately after initiation of the first administration of the investigational product to immediately before initiation of the first maintenance dose. 7) Proportion of patients with a over 50% reduction from baseline in the NRS score at each assessment time point up to the day after the final administration. 8) Trajectory of change from baseline in the NRS score up to immediately before administration of the second maintenance dose, stratified by the presence or absence of recurrence up to immediately before administration of the first maintenance dose. 9) Proportion of patients rated as effective on the physician's global impression score at the assessment time points of 120 minutes after initiation of the first administration of the investigational product, the day after the first administration, and the day after the final administration. 10) Proportion of patients rated as effective on the patient's global impression score at the assessment time points of 120 minutes after initiation of the first administration of the investigational product, the day after the first administration, and the day after the final administration. 11) Change from baseline in the EQ-5D-5L quality-of-life index value.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	<Items to be checked during registration and allocation> (1) Patients aged 18 years or older at the time of informed consent. (2))Patients diagnosed with trigeminal neuralgia; 13.1.1.1 Classical trigeminal neuralgia and 13.1.1.3 Idiopathic trigeminal neuralgia, according to the International Classification of Headache Disorders 3rd edition (ICHD3). (3)At the time of enrollment, patients whose trigeminal neuralgia-related pain intensity was 5 or higher on the Numerical Rating Scale (NRS) when they personally performed daily activities that trigger pain. (4)Patients who are able to perform NRS self-assessment appropriately. (5)Patients who gave written informed consent based on their own free will after receiving adequate explanation and fully understanding the details of the explanation in participating in the study. <Items to be checked immediately before the start of the initial dose> (6)Patients who, during the 2 hours immediately before the start of the initial dose, experienced frequent or persistent pain due to trigeminal neuralgia with an NRS score of 5 or higher, and for whom the investigator judged that therapeutic intervention with the study drug was necessary. The NRS score shall be assessed during daily life activities that trigger pain as performed by the subject, and pain with an NRS score of 5 or higher must be present at all three time points: 2 hours before, 60 minutes before, and immediately before the start of the initial dose.
Exclude criteria	(1)Patients who are suspected to be increased intracranial pressure. (2)Patients who are complicated with epilepsy, serious mental or neuropsychiatric disorders (including dementia, Parkinson's disease, or schizophrenia) or consciousness disturbance. (3) Patients who are being treated for malignancy. However, those who do not interfere with daily life and have good general condition may be included in the study. (4)Patients with suspected herpes zoster or postherpetic neuralgia (trigeminal area) (5)Patients who have other severe pain that may affect the assessment of pain associated with trigeminal neuralgia. (6)Patients who have sinus bradycardia or advanced conduction disturbance. (7)Patients who have a history of hypersensitivity to hydantoin. (8)Patients who are receiving drugs that are contraindicated in the package insert for fosphenytoin. (9)Patients who have serious cardiac disease, respiratory disorder, or hepatic or renal dysfunction. (10)Patients who received surgical treatment for the trigeminal neuralgia within 2 weeks of the study drug. (11)Patients who received fosphenytoin, phenytoin, ethotoin and their combination drugs within 2 weeks of the study drug. (12)Patients who have previously participated in the NPC-06-IFT trial or any clinical study and received fosphenytoin, or who have participated in the present trial and have been administered the investigational product. (13)Patients who have participated in other clinical study(exclude observational studies) within 3 months of the date of the study drug administration. (14)Pregnant women, lactating women or patients of childbearing potential during the study period. (15)Other patients who are deemed inappropriate for participation in the study by the investigators.