Biomarker and Genetic Predictors of Erenumab Treatment Response (INTERROGATE)
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|ClinicalTrials.gov Identifier: NCT04265755|
Recruitment Status : Not yet recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Erenumab||Phase 4|
This is a phase 4 open-label study aiming to explore the relationship between clinical response to erenumab and genetic biomarkers.
Subjects with episodic or chronic migraine will be treated with Erenumab 70mg or 140mg for a 4-week baseline/screening period, followed by a 24-week treatment period.
Subjects will collect migraine-related parameters daily using an eDiary and blood samples will be collected for biomarker research. All analysis will be descriptive in nature.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biomarker and Genetic Predictors of Erenumab Treatment Response, a Phase 4 Investigational Open-label Study (INTERROGATE)|
|Estimated Study Start Date :||April 19, 2020|
|Estimated Primary Completion Date :||October 3, 2021|
|Estimated Study Completion Date :||October 3, 2021|
Experimental: Single arm
Erenumab packed in a SureClick® Autoinjector Pen (AI)
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
- Achievement of at least a 50% reduction from baseline in mean monthly migraine days (MMD) in relation to each individual genome-wide significant single-nucleotide polymorphism (SNP) contributing to the migraine polygenic risk score (mPRS) [ Time Frame: From baseline over months 4, 5, and 6 ]To explore the relationship between clinical response to erenumab and genetic biomarkers
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): NCT04265755
|Contact: Amgen Call Centeremail@example.com|