A Phase 3, Double-Blind, Placebo-Controlled Study of NPC-06 in Patients with Trigeminal neuralgia

JRCT ID: jRCT2011220043

Registered date:03/03/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Trigeminal neuralgia
• Date of first enrollment: 25/04/2023
• Target sample size: 20
• 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 500 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 in the NRS pain score from baseline at 120 minutes after the study drug administration.

Secondary Outcome

(1)Change in the NRS pain score from baseline at each assessment time point up to 120 minutes after the first maintenance dose.
(2)Numbers of trigeminal neuralgia attacks from immediately after the study drug administration to immediately before the first maintenance dose.
(3)Change in the NRS pain score from baseline at each assessment time point after the study drug administration.
(4)Time to the first disappearance of the event (Time to event) during the period from immediately after the study drug administration to immediately before the first maintenance dose.
(5)The proportion of responders defined as a 50% reduction in NRS pain score from baseline to 120 minutes after the study drug administration.
(6)The improvement rate of patient impression scores at assessment time point of the day after the last dose.
(7) Change in the SF-8 (24-hour version) score for QOL from baseline.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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)Patients whose NRS pain score at the patient registration is 5 or higher.
(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.

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 participated in this study and recived the study drug
(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.

Related Information

• Primary Sponsor: Noro Shusaku
• Source(s) of Monetary Support: Nobelpharma Co., Ltd.