JPRN-jRCT2061220090
Recruiting
Phase 2
Safety and efficacy of Goreisan in combination with carbamazepine in patients with trigeminal neuralgia: A physician-initiated double-blind, randomized, placebo-controlled, Phase II clinical trial - HOG-503-001
Ogawa Keiko0 sites24 target enrollmentJanuary 30, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ogawa Keiko
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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