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Study Complete
Sponsor ID
20160172

AMG 334 20160172 Pediatric Migraine PK Study.

Sponsor ID
20160172
Clinicaltrials.gov ID
NCT03499119
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

AMG 334 20160172 Pediatric Migraine PK Study.

Additional Study Details

Phase
Phase 1
Product
Erenumab
Type
Interventional
Masking
None (Open Label)
Enrollment
53
Additional Study Details

Protocol Summary

Primary Outcome Measures

Serum PK parameter of AMG 334 maximum observed concentration [Cmax]

Timeframe: 12 weeks for subjects completing initial treatment period

Serum PK parameter of AMG 334 time to maximum concentration [tmax]

Timeframe: 12 weeks for subjects completing initial treatment period

Serum PK parameter of AMG 334 area under the concentration time curve from 0 to 28 days [AUC 0-28days]

Timeframe: 12 weeks for subjects completing initial treatment period

Serum PK parameter of AMG 334 trough concentration [Ctrough]

Timeframe: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension

Treatment-emergent adverse events

Timeframe: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension

Heart Rate

Timeframe: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension

Body Temperature

Timeframe: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension

Blood Pressure

Timeframe: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension

Duration and morphology of P, QRS and T waves in 12-lead electrocardiograms (ECGs)

Timeframe: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension

Standard Hematology Lab Assessments

Timeframe: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension

Standard Chemistry

Timeframe: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension

Standard sensory assessment of body and peripheral and central nervous systems

Timeframe: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension

Standard motor assessment of body peripheral and central nervous systems

Timeframe: 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension

Secondary Outcome Measures
Not Available

Locations

Location
Status
Contact Us
Location
Cincinnati Childrens Hospital Medical Center
Cincinnati, OH, United States, 45229
Status
Recruiting
Location
Clinical Research Institute Inc
Plymouth, MN, United States, 55441
Status
Terminated
Location
Premiere Research Institute
West Palm Beach, FL, United States, 33407
Status
Terminated
Location
Arkansas Childrens Hospital
Little Rock, AR, United States, 72202
Status
Terminated
Location
PANDA Neurology and Atlanta Headache Specialists
Atlanta, GA, United States, 30328
Status
Terminated
Location
Childrens Mercy Hospital
Kansas City, MO, United States, 64108
Status
Recruiting
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Study Info
Age
6 - 17 Years
Condition
  • Migraine
    • Sex
    All
    Trial Dates
    May 2018 - Nov 2021
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    -Subject’s legally acceptable representative has provided informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated. -Male and female children and adolescents ≥ 6 and <18 years of age upon entry into screening -Diagnosis of migraines, with or without aura, according to the International Classification of Headache Disorders (ICHD 3rd Edition, 2013) for at least 12 months prior to the study screening -Frequency of migraine of ≥ 4 migraine days per month in each of the 3 months prior to the study screening period
    Exclusion Criteria:
    -Currently receiving treatment in another investigational device or drug study -History of migraine with brainstem aura or hemiplegic migraine headache -Medical history or other condition that compromises the ability of the subject or legally acceptable representative to give appropriate informed consent and/or assent -Malignancy except non-melanoma skin cancers or cervical cancer in situ within the last 5 years. -Presence of any clinical condition that in opinion of the investigator might increased the risk of subjects participating in the study.