Study Complete
Sponsor ID
20190008

Erenumab – Comprehensive Assessment of Efficacy in (High-Frequency) Episodic MigraineEMBRACE

Sponsor ID
20190008
Clinicaltrials.gov ID
NCT04252742
EUCTIS ID
N/A
EudraCT ID
2019-003646-33

Study Details

The primary objective of this study is to evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.

Additional Study Details

Phase
Phase 4
Product
Erenumab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
512
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change from baseline in mean monthly hours of at least moderate headache pain intensity, with pain intensity measured by the 11-point NRS scale

Timeframe: Over months 1, 2, and 3

Secondary Outcome Measures

Change from baseline in mean monthly physical function domain score as measured by the Migraine Functional Impact Questionnaire (MFIQ)

Timeframe: Over months 1, 2, and 3

Change from baseline in the mean monthly impact on usual activities domain score as measured by the MFIQ

Timeframe: Over months 1, 2, and 3

Change from baseline in the mean monthly impact on emotional function domain score as measured by the MFIQ

Timeframe: Over months 1, 2, and 3

Change from baseline in the mean monthly impact on social function domain score as measured by the MFIQ

Timeframe: Over months 1, 2, and 3

Change from baseline in mean monthly average duration of at least moderate pain intensity in qualifying migraine attacks, with pain measured by the 11-point NRS scale

Timeframe: Over months 1, 2, and 3

Change from baseline in mean monthly average peak migraine pain intensity as assessed by the 11-point Numeric Rating Scale (NRS)

Timeframe: Over months 1, 2, and 3

Locations

Location
Status
Contact Us
Location
AppleTreeClinics Network Spzoo
Lodz, Poland, 90-349
Status
Recruiting
Location
NZOZ Neuromed M i M Nastaj Spolka Partnerska
Lublin, Poland, 20-064
Status
Recruiting
Location
Dent Neurosciences Research Center
Amherst, NY, United States, 14226
Status
Recruiting
Location
Michigan Head Pain and Neurological Institute
Ann Arbor, MI, United States, 48104
Status
Recruiting
Location
Mountain Neurological Research Center
Basalt, CO, United States, 81621
Status
Terminated
Location
Uno Medical Trials Kft
Budapest, Hungary, 1135
Status
Completed
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