Clinical trial NCT02542605: To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients
Official title: Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Keywords: Migraine
Headache
Migraine Headache
Headache, Migraine
Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients.


Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 to ≤ 45 years of age upon entry into screening
* History of migraine headaches without aura for ≥ 6 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-II) (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report
* Migraine frequency: ≥ 1 and ≤ 5 migraine days per month in each of the 3 months prior to screening

Exclusion Criteria:

* History of migraine with aura, cluster headache or hemiplegic migraine headache according to the IHS Classification ICHD-II (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report
* ≥ 6 migraine days per month in the last 3 months prior to study enrollment and during screening period
* Other headache disorders (except for episodic tension-type headache \<5 days/month)

Primary outcomes:
measure: Number of Participants With a MLA Within 24 Hours of Challenge Agent Infusion
timeFrame: Part B randomization phase day 8 plus 24 hours.
Secondary outcomes:
measure: Number of Participants With a Headache Within 24 Hours of Challenge Agent Infusion
timeFrame: Part B randomization phase day 8 plus 24 hours.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Part B randomization phase day 1 until EOS (up to 12 weeks).
measure: Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS
timeFrame: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
measure: Mean Change From Baseline in Heart Rate at Day 1, Day 8 and EOS
timeFrame: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
measure: Mean Change From Baseline in Respiratory Rate at Day 1, Day 8 and EOS
timeFrame: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
measure: Mean Change From Baseline in Temperature at Day 1, Day 8 and EOS
timeFrame: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
measure: Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS
timeFrame: Part B randomization phase baseline and day 8, day 9 and EOS (week 12).
measure: Mean Change From Baseline in Total Bilirubin at Day 8, Day 9 and EOS
timeFrame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
measure: Mean Change From Baseline in Blood Urea at Day 8, Day 9 and EOS
timeFrame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
measure: Mean Change From Baseline in Creatine Kinase at Day 8, Day 9 and EOS
timeFrame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
measure: Mean Change From Baseline in Creatinine at Day 8, Day 9 and EOS
timeFrame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
measure: Mean Change From Baseline in Direct Bilirubin at Day 8, Day 9 and EOS
timeFrame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
measure: Mean Change From Baseline in Eosinophil Count at Day 8, Day 9 and EOS
timeFrame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
measure: Mean Change From Baseline in Blood Glucose at Day 8, Day 9 and EOS
timeFrame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
measure: Mean Change From Baseline in Hemoglobin A1C (Fraction of 1) at Day 8, Day 9 and EOS
timeFrame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
measure: Pharmacokinetics (PK): Mean Erenumab Serum Concentration at 1 Hour (C1h)
timeFrame: Part B randomization phase 1 hour post-dose day 1.
measure: PK: Mean Area Under the Concentration-time Curve From Time 0 to 84 Days Post-dose (AUC84d)
timeFrame: Part B randomization phase baseline and 84 days post-dose.
measure: Number of Participants With Anti-Erenumab Antibodies
timeFrame: Part B randomization phase baseline and EOS.
measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
timeFrame: Part B randomization phase baseline and EOS.
measure: Number of Participants With Clinically Significant Changes in Physical Parameters
timeFrame: Part B randomization phase baseline and EOS.
measure: Number of Participants With Clinically Significant Changes in Neurological Assessments
timeFrame: Part B randomization phase baseline and EOS.
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Research Site
state: California
city: Leuven
country: Belgium
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: