Randomized study of CGRP monoclonal antibodies for migraine

JRCT ID: jRCT1041230151

Registered date:14/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: migraine (high frequent episodic migraine, chronic migraine, medication-overuse headach)
• Date of first enrollment: 14/02/2024
• Target sample size: 60
• Study type: Interventional

Intervention(s)

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 symptoms will have a recurrence. We will validate these two research hypotheses.

1) CGRP monoclonal antibodies to be administered will be randomly determined at the time of enrollment in this study. During the period of administration of CGRP monoclonal antibodies, the patient will continue to use the prophylactic drugs and acute treatment drugs used for headaches as they were before administration.
2) For 4 weeks after the first administration of CGRP monoclonal antibodies, calculate the number of headache days, migraine days, and acute medication use (number of times/week) for each week. In addition, a questionnaire will be administered 4 weeks after the first dose to see when the effects will be felt.
3) CGRP monoclonal antibodies are administered every 4 weeks, and the same drug is administered continuously until the third dose. Various evaluation items will be conducted before the first dose and 4 weeks after each dose. Effectiveness is defined as a 50% or more decrease in the number of headache days per month compared to the 4 weeks before administration of CGRP monoclonal antibodies, and ineffectiveness is defined as a decrease of less than 25%. If the drug is effective 4 weeks after the third dose, continue administering the same drug up to the sixth dose. If it is ineffective at this point, administration of CGRP monoclonal antibodies will be discontinued and participation in this study will be terminated.
4) In all cases, CGRP monoclonal antibodies have been administered 6 times, administration of CGRP monoclonal antibodies should be discontinued (drug suspension) after the 6th dose. During the drug withdrawal period, continue to use the prophylactic drugs and acute treatment drugs used for headaches as before.
5) Various evaluation items will be conducted every 4 weeks during the drug withdrawal period. Patients will be followed up until 12 weeks after drug discontinuation, at which point the study will end.
6) Relapse is defined as 8 or more days of headache in the 4 weeks after discontinuing the drug. If headache symptoms have a recurrence during the drug discontinuation period, restart the same CGRP monoclonal antibody as before drug discontinuation (re-administration). In the case of readministration, various evaluation items will be conducted 4 weeks after readministration, and the study will end at that point.
7) In the exploratory evaluation, the number of headache days, migraine days, drug usage, etc. will be calculated by analyzing headache diaries using AI.

Outcome(s)

• Primary Outcome: Comparison of immediate effects of galcanezumab and other drugs (fremanezumab, erenumab) one week after the first administration.

Secondary Outcome

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 related to this research.
Exploratory evaluation
Examine the changes in the number of headache days, migraine days, amount of acute treatment drugs used, and various evaluation items for each month during the 4th to 6th administration of CGRP monoclonal antibodies and the drug withdrawal period.
Analyze headache diary, pre-examination questionnaire, various evaluations, clinical data, etc. using AI.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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
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Related Information

• Primary Sponsor: Saito Ryuta