Placebo-controlled randomized controlled phase II trial of Goreisan in combination with carbamazepine in patients trigeminal neuralgia

Phase 2

Recruiting

• Conditions: trigeminal neuralgia; trigeminal neuralgia, idiopathic trigeminal neuralgia, typical trigeminal neuralgia, carbamazepine refractory; D014277

• Registration Number: JPRN-jRCT2061220090
• Lead Sponsor: Ogawa Keiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-30
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Select patients who meet all of the following criteria
(1) Patients whose consent has been obtained in writing
(2) Patients who are at least 18 years of age at the time consent is obtained, regardless of gender
(3) Patients who can use a telemedicine system
(4) Patients diagnosed with idiopathic trigeminal neuralgia or typical trigeminal neuralgia based on the diagnostic criteria according to The International Classification of Headache Disorders (ICHD, 3DE EDTION: ICHD-3)
(5) Patients who meet the following conditions for carbamazepine for trigeminal neuralgia at the time of enrollment
-Receiving carbamazepine for at least 1 month consecutively
-Daily dosage has remained unchanged for 2 weeks prior to enrollment.
(6) Patients with inadequate pain control for trigeminal neuralgia even with carbamazepine administration*.
*Average weekly VAS 30 or greater for pain attacks in 1 consecutive week within 3 weeks prior to enrollment
(7) Women of childbearing potential with a confirmed negative pregnancy test within 14 days prior to enrollment
(8) For women of childbearing potential or with a partner of childbearing potential, patients who have agreed to use an appropriate contraceptive method from the time consent is obtained to 6 months after the last dose of protocol treatment

Exclusion Criteria

(1) Patients diagnosed with secondary trigeminal neuralgia
(2) Patients with a history of allergic reaction to any of the ingredients in Goreisan
(3) Patients with a history of Goreisan, Inchin goreisan, Tyoreitou, or Ireitou.
(4) Patients who are using any of the following drugs within 30 days prior to registration
Drugs that have been reported to be effective for trigeminal neuralgia
Drugs contraindicated with carbamazepine
Kampo and crude drug containing the ingredients of Goreisan
(5) Patients on drugs that are contraindicated with carbamazepine
(6) Patients undergoing treatment for malignant tumors
(7) Pregnant or breast-feeding women
(8) Patients who have undergone major surgery within 8 weeks prior to screening or who are planned to undergo surgery during the study period
(9) Patients with clinically significant cardiac disease (myocardial infarction within 1 year, unstable ischemic heart disease, NYHA classification III / IV left ventricular failure, arrhythmia, and uncontrolled hypertension, etc.), hematological disorders, neurological diseases, psychiatric disorders, etc. or porphyria
(10) Patients with the following laboratory values at screening
- Hemoglobin level: less than 10 g/dL
- Platelet count: less than 100000/mm3
- White blood cell count: <3000/mm3
- AST and ALT: > 1.5 times the upper limit of the institutional reference value (ULN)
- Serum creatinine level: ULN > 1.5 times the ULN
(11) Patients with chronic pain other than trigeminal neuralgia that the investigator or subinvestigator diagnoses may affect the evaluation of the study
(12) Patients who have received other investigational drugs within 30 days of enrollment in the study
(13) Other patients who the investigator determines to be inappropriate as subjects for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified