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

JRCT ID: jRCT2061220090

Registered date:30/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: trigeminal neuralgia
• Date of first enrollment: 02/11/2023
• Target sample size: 24
• Study type: Interventional

Intervention(s)

investigational drug: Goreisan: 2.5 g 3 times/day taken orally before meals for 4 weeks
Comparator Product: Placebo granules: 2.5 g 3 times/day taken orally before meals for 4 weeks
Carbamazepine will be continued without changing the dose at the time of registration.

Outcome(s)

Primary Outcome

Change from baseline in the average VAS* (Visual Analogue Scale) for one week of pain attacks at the 4-week time point
* Using the VAS evaluation chart (paper), the total VAS of pain attacks occurring in a day was divided by the number of attacks to obtain the average daily pain attack VAS, which was then averaged over 7 consecutive days.

Secondary Outcome

(1) Change from baseline in pain attack 1-week average VAS
(2) Treatment failure rate: Percentage increase from baseline of pain attack 1-week average VAS by 50% or more
(3) Treatment response rate: Percentage of pain attack 1-week average VAS decreasing by 30% or more from baseline
(4) Change from baseline in worst 24-hour VAS
(5) Change from baseline in the number of 24-hour pain attacks
(6) Change from baseline in the total value measured by the brief pain questionnaire
(7) Change from baseline in total values measured by the Pain Questionnaire
(8) Change from baseline in total values measured by the Pittsburgh Sleep Questionnaire
(9) Amount of change in quality of life
(10) Change in mental status
(11) Compliance with Goreisan
(12) Percentage of adverse events
(13) Carbamazepine blood level

Key inclusion & exclusion criteria

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

Include 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

Exclude 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 28 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.

Related Information

• Primary Sponsor: Ogawa Keiko
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development