LOMCAD Trial

• Register: JPRN
• Last refreshed on: 1 April 2024
• Main ID: JPRN-jRCTs051220072
• Date of registration: 09/08/2022
• Prospective Registration: Yes
• Primary sponsor: Ohara Tomoyuki
• Public title: LOMCAD Trial
• Scientific title: Effect of Lomerizine Hydrochloride on Preventing Recurrence of Cerebral Ischemic Events in Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy - LOMCAD
• Date of first enrolment: 28/11/2022
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs051220072
• Study type: Interventional
• Study design: single arm study, open(masking not used), historical control, single assignment, treatment purpose
• Phase: N/A

Contacts

• Name: Ikuko Mizuta
• Affiliation: Graduate School of Medical Science, Kyoto Prefectural University of Medicine

• Name: Tomoyuki Ohara
• Affiliation: University Hospital Kyoto Prefectural University of Medcine

Key inclusion & exclusion criteria

Inclusion criteria: Patients 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.
Exclusion criteria: Patients 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.

Age minimum: >= 20age old
Age maximum: <= 70age old
Gender: Both

Health Condition(s) or Problem(s) studied

Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL)
CADASIL

D046589

Intervention(s)

Lomerizine hydrochloride (MIGSYS tablets 5 mg, 1 tablet twice daily) will be administered continuously for 24 months as the study drug.

Primary Outcome(s)

Symptomatic cerebral ischemic events during the 24 months following start of study treatment

Secondary Outcome(s)

1) 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)

Source(s) of Monetary Support

Japan Agency for Medical Research and Development

Secondary Sponsor(s)

Mizuno Toshiki

Ethics review

Status: Approval
Approval date: 22/07/2022
Contact:

[e-mail]

Certified Review Board, Kyoto Prefectural University of Medicine

[phone]

[e-mail]