Recruitment Complete
Sponsor ID
20160354

Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic MigraineOASIS(CM)

Sponsor ID
20160354
Clinicaltrials.gov ID
NCT03832998
EUCTIS ID
N/A
EudraCT ID
2023-504928-26

Study Details

This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine. The study hypothesis is that in pediatric participants with chronic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).

Additional Study Details

Phase
Phase 3
Product
AMG 334
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
284
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change from baseline in MMDs

Timeframe: Baseline through week 12 of DBTP

Secondary Outcome Measures

Change in monthly headache days from baseline

Timeframe: Baseline through week 12 of the DBTP

Proportion of participants with at least 50% reduction in MMDs from baseline

Timeframe: Baseline through week 12 of the DBTP

Change in MMDs from baseline to the average of the first 3 months

Timeframe: Baseline through week 12 of the DBTP

Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)

Timeframe: Baseline through week 12 of the double blind treatment phase

Change from baseline in migraine-related disability and productivity as assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)

Timeframe: Baseline through week 12 of the DBTP

Number of participants experiencing Treatment-emergent Adverse Events (TEAE)

Timeframe: Up to Week 83

Number of participants expressing C Terminal Telopeptide of Type 1 Collagen (CTX) Markers

Timeframe: Up to week 83

Number of participants expressing Procollagen Type 1 N Propeptide (P1NP) Markers

Timeframe: Up to week 83

Number of participants expressing Anti-erenumab antibodies

Timeframe: Up to week 83

Change in growth and development rate as assessed by physical measuraments based on age-adjusted Z-scores for height and weight

Timeframe: Up to week 83

Number of participants experiencing treatment-emergent suicidal ideation and behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).

Timeframe: Up to week 83

Group 1 only: Number of participants experiencing injection site pain as assessed by Face Pain Scale-revised (FPS-R)

Timeframe: Day 1 and week 20

Group 2 only: Number of participants experiencing injection site pain as assessed by FPS-R

Timeframe: Day 1 and week 8

Locations

Location
Status
Contact Us
Location
Preferred Primary Care Physicians, Inc
Pittsburgh, PA, United States, 15236
Status
Terminated
Location
New England Regional Headache Center Inc
Worcester, MA, United States, 14226
Status
Terminated
Location
Dent Neurosciences Research Center
Amherst, NY, United States, 14226
Status
Terminated
Location
Josephson Wallack Munshower Neurology
Indianapolis, IN, United States, 46256
Status
Recruiting
Location
Michigan Head Pain and Neurological Institute
Ann Arbor, MI, United States, 48104
Status
Recruiting
Location
Premiere Research Institute
West Palm Beach, FL, United States, 33407
Status
Terminated
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