Randomized study of CGRP monoclonal antibodies for migraine

Randomized comparative study of calcitonin gene-related peptide monoclonal antibodies for migraine

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1041230151

Enrollment

Registered

2024-02-14

Start date

2024-04-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

migraine (high frequent episodic migraine, chronic migraine, medication-overuse headach)

Interventions

For migraine, galcanezumab has a shorter period from initial administration to onset of effect than other drugs (fremanezumab, erenumab). If CGRP monoclonal antibodies are discontinued, headache sympt

migraine, CGRP monoclonal antibodies, discontinued

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients who have been diagnosed with high frequent episodic migraine or chronic migraine (including medication-overuse headache) and have headaches for 8 or more days per month -No intracranial disease found on head MRI/A -18 years of age or older -Meets the criteria for use of CGRP monoclonal antibodies -Patients who have obtained written consent fromthe patient

Exclusion criteria

Exclusion criteria: -Patients with intracranial disease -Patients with serious complications (liver disease, kidney disease, heart disease, lung disease, blood disease, brain disease, etc.) -Pregnant or potentially pregnant patients -Breastfeeding patient -Patients who are considered as inappropriate by a head of research or research assignations -

Design outcomes

Primary

Measure	Time frame
Comparison of immediate effects of galcanezumab and other drugs (fremanezumab, erenumab) one week after the first administration.	—

Secondary

Measure	Time frame
1) Comparison of immediate effects of fremanezumab adn erenumab one week after the first administration The following secondary endpoints are comparisons between galcanezumab and other drugs (fremanezumab, erenumab) and between fremanezumab and erenumab. 2) Compare the number of headache days, migraine days, and acute medication use for each week between the weekly average before administration of CGRP monoclonal antibodies and 4 weeks after the first administration. 3) Comparison of subjective effect onset timing of first administration of CGRP monoclonal antibodies. 4) Compare the number of headache days, migraine days, amount of acute medication use, and trends in various evaluation items for each month after each administration from the 1st to 3rd administration of CGRP monoclonal antibodies. 5) Comparing the efficacy rate 4 weeks after the first and third administration of CGRP monoclonal antibodies. 6) Comparing the improvement rate of depression score before administration of CGRP monoclonal antibodies and 4 weeks after the third administration. 7) Compare the days of absenteeism and presenteeism for each month before administration of CGRP monoclonal antibodies and after the first to third administration. 8) Comparison of the proportion of cases in which CGRP monoclonal antibodies did not respond (including cases of discontinuation) 4 weeks after the third administration of CGRP monoclonal antibodies. 9) Comparison of migraine recurrence rate and timing up to 12 weeks after discontinuation of CGRP monoclonal antibodies. 10) Comparison of the efficacy rate of re-administration of CGRP monoclonal antibodies to patients with migraine relapse and the number of headache days, migraine days, and various scores before and after re-administration. 11) Detection and comparison of clinical factors before administration of CGRP monoclonal antibodies and factors related to effective cases 4 weeks after the first and third administration. 12) Extraction of diseases relat	—

Measure

Time frame

1) Comparison of immediate effects of fremanezumab adn erenumab one week after the first administration The following secondary endpoints are comparisons between galcanezumab and other drugs (fremanezumab, erenumab) and between fremanezumab and erenumab. 2) Compare the number of headache days, migraine days, and acute medication use for each week between the weekly average before administration of CGRP monoclonal antibodies and 4 weeks after the first administration. 3) Comparison of subjective effect onset timing of first administration of CGRP monoclonal antibodies. 4) Compare the number of headache days, migraine days, amount of acute medication use, and trends in various evaluation items for each month after each administration from the 1st to 3rd administration of CGRP monoclonal antibodies. 5) Comparing the efficacy rate 4 weeks after the first and third administration of CGRP monoclonal antibodies. 6) Comparing the improvement rate of depression score before administration of CGRP monoclonal antibodies and 4 weeks after the third administration. 7) Compare the days of absenteeism and presenteeism for each month before administration of CGRP monoclonal antibodies and after the first to third administration. 8) Comparison of the proportion of cases in which CGRP monoclonal antibodies did not respond (including cases of discontinuation) 4 weeks after the third administration of CGRP monoclonal antibodies. 9) Comparison of migraine recurrence rate and timing up to 12 weeks after discontinuation of CGRP monoclonal antibodies. 10) Comparison of the efficacy rate of re-administration of CGRP monoclonal antibodies to patients with migraine relapse and the number of headache days, migraine days, and various scores before and after re-administration. 11) Detection and comparison of clinical factors before administration of CGRP monoclonal antibodies and factors related to effective cases 4 weeks after the first and third administration. 12) Extraction of diseases relat

—

Contacts

Public ContactTakafumi Tanei

Nagoya University, Graduate School of Medicine

tanei@med.nagoya-u.ac.jp+81-52-744-2353

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026