Tokyo, April 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061371) titled 'Triptans and lasmiditan in patients with migraine attacks associated with neurodevelopmental disorders' on April 24.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
Condition:
Condition - patients with migraine attacks accompanied by neurodevelopmental disorders
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Triptans and lasmiditan are considered specific acute medications for migraine attacks. Despite the efficacy of these treatments, continuation of these medications was limited because some patients experienced adverse effects. A previous study reported a close association between migraine and neurodevelopmental disorders. The present study investigated triptans and lasmiditan in the treatment of consecutive patients with migraine attacks accompanied by neurodevelopmental disorders.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Triptan and/or lasmiditan tablets were prescribed for consecutive patients after the diagnosis of migraine attacks and neurodevelopmental disorders. Triptans, eletriptan or zolmitriptan was prescribed. However, in this study, lasmiditan was used at a dose of 50 mg because the 100 mg dose led to greater adverse effects in Japanese patients.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - All patients were diagnosed with migraine by a certified headache specialist according to the International Classification of Headache 3rd edition. For all patients, brain magnetic resonance imaging was performed, and other organic lesions causing headache were eliminated. Before this study, neurodevelopmental disorders were diagnosed by several specialists.
Key exclusion criteria - Patients who could not express their headaches and the effect of the drugs.
Target Size - 20
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 01 Month 01 Day
Date of IRB - 2025 Year 03 Month 26 Day
Anticipated trial start date - 2025 Year 03 Month 27 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070219
Disclaimer: Curated by HT Syndication.