NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051220072

Registered date:09/08/2022

LOMCAD Trial

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedCerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL)
Date of first enrollment28/11/2022
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Lomerizine hydrochloride (MIGSYS tablets 5 mg, 1 tablet twice daily) will be administered continuously for 24 months as the study drug.

Outcome(s)

Primary OutcomeSymptomatic cerebral ischemic events during the 24 months following start of study treatment
Secondary Outcome1) Number of symptomatic cerebral ischemic events during the 24 months following start of study treatment 2) Incidence of all cerebral ischemic events during the 24 months following start of study treatment 3) Changes in modified Rankin Scale (mRS)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 70age old
GenderBoth
Include criteriaPatients meeting all of the following criteria will be included 1) Patients diagnosed with CADASIL by genetic testing 2) Patients with "symptomatic cerebral infarction, transient ischemic attack, or asymptomatic MRI diffusion-weighted imaging (DWI) detection of acute ischemic lesions" within 6 months prior to obtaining consent, and once or more within 2 years prior to the most recent "symptomatic cerebral infarction, transient ischemic attack, or asymptomatic head MRI DWI detection of acute ischemic foci" . 3) Patients who are between 20 and 70 years of age at the time of consent 4) Patients who have obtained written consent from the patient or a surrogate to participate in the clinical trial.
Exclude criteriaPatients who fall into any of the following categories will not be included in this study 1) Patients who have taken lomerizine hydrochloride for more than 1 month continuously within 1 year prior to enrollment 2) Patients with a history of hypersensitivity to lomerizine hydrochloride 3) Patients with a history of symptomatic intracranial hemorrhage 4) Patients who are unable to discontinue acetazolamide medication 5) Patients on concomitant antiplatelet and anticoagulant medications or taking two or more antiplatelet medications at the time of enrollment 6) Patients with severe hepatic dysfunction at the time of enrollment 7) Women who wish to become pregnant during the study period, are pregnant, may become pregnant, or are breastfeeding at the time of consent 8) Patients with a modified Rankin Scale (mRS) of 4 or higher at the time of enrollment 9) Patients who are unable to undergo MRI examinations (claustrophobia, metal in the body, etc.) 10) Patients who cannot have a baseline MRI examination at the study site within 42 days prior to enrollment 11) Patients who are participating in another clinical trial at the time of consent 12) Other patients who are deemed by the investigator to be inappropriate to participate in the clinical trial.

Related Information

Contact

Public contact
Name Ikuko Mizuta
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan Kyoto Japan 602-8566
Telephone +81-75-251-5793
E-mail lomcad@koto.kpu-m.ac.jp
Affiliation Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Scientific contact
Name Tomoyuki Ohara
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan Kyoto Japan 602-8566
Telephone +81-75-251-5793
E-mail lomcad@koto.kpu-m.ac.jp
Affiliation University Hospital Kyoto Prefectural University of Medcine