Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab
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|ClinicalTrials.gov Identifier: NCT04592952|
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Calcitonin Gene-Related Peptide Drug: Erenumab||Phase 4|
This is a single-center, non-randomized, single-arm, open-label study, in which adults with episodic or chronic migraine will receive intravenous infusion with calcitonin gene-related peptide and subsequently be treated with erenumab. The study will consist of the following elements:
- Provocation Phase (1 experimental day with intravenous infusion of calcitonin gene-related peptide)
- Screening/Baseline Phase (4 weeks)
- Open-Label Treatment Phase (24 weeks)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab|
|Estimated Study Start Date :||October 8, 2020|
|Estimated Primary Completion Date :||August 1, 2025|
|Estimated Study Completion Date :||August 1, 2025|
Provocation Phase: Intravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes.
Open-Label Treatment Phase: Erenumab packed in a SureClick® Autoinjector Pen (AI)
Drug: Calcitonin Gene-Related Peptide
Intravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes.
Other Name: CGRP
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
Other Name: Aimovig
- Headache Diary (Baseline Phase and Treatment Phase) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 24 ]Headache diary with daily entries to record migraine-related data (e.g. migraine days, headache days, number of days with use of acute migraine medication, number of days with aura).
- Headache Diary (Provocation Phase) [ Time Frame: Provocation Phase (12 Hours) ]Subjects will be instructed to fill out a headache diary during the 12-hour observational period. The diary will be used to record migraine-related data (e.g. location, quality, intensity, aggravation by routine physical activity, use of acute migraine medication, nausea, vomiting, photophobia, and phonophobia)
- Semi-Structured Interview [ Time Frame: 1 Hour ]In-person semi-structured interview to record migraine-related data (e.g. location, quality, intensity, aggravation by routine physical activity, use of acute migraine medication, nausea, vomiting, photophobia, phonophobia, premonitory symptoms, postdromal symptoms, trigger factors, autonomic symptoms).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04592952
|Contact: Messoud Ashina, MDfirstname.lastname@example.org|
|Contact: Hakan Ashina, MDemail@example.com|
|Principal Investigator:||Messoud Ashina, MD||Danish Headache Center|