AMG 334 20160172 Pediatric Migraine PK Study.
Study Details
Study Description
Brief Summary
AMG 334 20160172 Pediatric Migraine PK Study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
An Open-label, Randomized, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Cohort 1 Subjects with a body weight at Day 1 of less than weight threshold. |
Drug: AMG 334 Dose 1
Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.
Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2
Drug: AMG 334 Dose 3
Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.
|
| Other: Cohort 2 Subjects with a body weight at Day 1 of weight threshold or more. |
Drug: AMG 334 Dose 1
Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.
Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2
Drug: AMG 334 Dose 2
Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2.
|
Outcome Measures
Primary Outcome Measures
- Serum PK parameter of AMG 334 maximum observed concentration [Cmax] [12 weeks for subjects completing initial treatment period]
- Serum PK parameter of AMG 334 time to maximum concentration [tmax] [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] [12 weeks for subjects completing initial treatment period]
- Serum PK parameter of AMG 334 trough concentration [Ctrough] [12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension]
- Treatment-emergent adverse events [12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension]
- Heart Rate [12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension]
- Body Temperature [12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension]
- Blood Pressure [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) [12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension]
- Standard Hematology Lab Assessments [12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension]
- Standard Chemistry [12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension]
Including liver function
- Standard sensory assessment of body and peripheral and central nervous systems [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 [12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arkansas Childrens Hospital | Little Rock | Arkansas | United States | 72202 |
| 2 | CarePoint | Englewood | Colorado | United States | 80112 |
| 3 | New England Institute for Clinical Research | Stamford | Connecticut | United States | 06905 |
| 4 | Synergy Health | Bradenton | Florida | United States | 34208 |
| 5 | Premiere Research Institute | West Palm Beach | Florida | United States | 33407 |
| 6 | PANDA Neurology and Atlanta Headache Specialists | Atlanta | Georgia | United States | 30328 |
| 7 | Riley Hosptial | Indianapolis | Indiana | United States | 46202 |
| 8 | Clinical Research Institute Inc | Plymouth | Minnesota | United States | 55441 |
| 9 | Childrens Mercy Hospital | Kansas City | Missouri | United States | 64108 |
| 10 | Meridian Clinical Research | Hastings | Nebraska | United States | 68901 |
| 11 | Dent Neurosciences Research Center | Amherst | New York | United States | 14226 |
| 12 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
| 13 | Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 14 | Nationwide Childrens Hospital | Columbus | Ohio | United States | 43205 |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20160172