A Safety and Efficacy Study to Evaluate AMG 334 in Migraine Prevention
NCT02630459 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 475
Last updated 2022-10-12
Summary
Randomized, double-blind, placebo-controlled, parallel-group, multicenter study followed by an open-label treatment phase (OLTP). To evaluate the effect of erenumab (AMG 334) compared to placebo on the change from baseline in monthly migraine days.
Conditions
Interventions
- DRUG
-
placebo via subcutaneous injection
- DRUG
-
Erenumab
erenumab via subcutaneous injection
- DRUG
-
Erenumab
erenumab via autoinjector (AI)/pen
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-06
- Primary Completion
- 2017-09-25
- Completion
- 2019-06-05
- FDA Drug
- Yes
Countries
- Japan
Study Locations
More Related Trials
-
A Controlled Trial of Erenumab in Migraine Prevention
NCT03812224 ·Status: COMPLETED ·Phase: PHASE3
-
Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients
NCT01723514 ·Status: COMPLETED ·Phase: PHASE1
-
Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and Migraine Patients
NCT01688739 ·Status: COMPLETED ·Phase: PHASE1
-
To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients
NCT02542605 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
NCT03333109 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Sustained Benefit of AMG334 in Adult Episodic Migraine Patients
NCT03927144 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
NCT03238781 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan
NCT02741310 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Intravenous Erenumab in Patients With Status Migrainosus
NCT04920331 ·Status: WITHDRAWN ·Phase: PHASE1
-
Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine
NCT04252742 ·Status: COMPLETED ·Phase: PHASE4
-
A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies
NCT03096834 ·Status: COMPLETED ·Phase: PHASE3
-
Phase I, Double-Blind,Placebo, MAD Study to Evaluate the Safety, Tolerability, PK, and PD of AMG 333 in Healthy Subjects and Migraine Subjects
NCT02132429 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache
NCT03971071 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients
NCT03867201 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)
NCT05399459 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of LY3451838 in Participants With Migraine
NCT04498910 ·Status: COMPLETED ·Phase: PHASE2
-
Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine
NCT04921384 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine
NCT03836040 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments
NCT04418765 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine
NCT04825678 ·Status: COMPLETED ·Phase: PHASE4
-
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
NCT04084314 ·Status: COMPLETED ·Phase: PHASE4
-
Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines
NCT01953341 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine
NCT03912337 ·Status: TERMINATED ·Phase: PHASE4
-
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
NCT03832998 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Tolerability of Erenumab in the Prophylactic Treatment of Persistent Post-Traumatic Headache
NCT03974360 ·Status: COMPLETED ·Phase: PHASE2