Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients

Episodic Migraine Clinical Trial

— EMPOwER  

Official title:

A 12-week Double-blind, Randomized, Multi-center Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous AMG 334 Against Placebo in Adult Episodic Migraine Patients (EMPOwER)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03333109
• Other study ID #: CAMG334A2302
• Status: Completed
• Phase: Phase 3
• Start date: February 8, 2018
• Est. completion date: January 13, 2020

Study information

• Verified date: October 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine

Description:

This study used a single-cohort, 3-treatment arm, randomized, double-blind study design in adult patients with episodic migraine. The subjects were randomized to receive either erenumab or placebo in a 2:3:3 ratio (erenumab 140 mg: erenumab 70 mg: placebo). A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period. After randomization/Day 1, visits occurred at four week intervals until Week 12, which was the End of Treatment. The final visit, Last Patient Last Visit was a Safety Follow-Up visit, which occurred 12 weeks later, at Week 24.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: January 13, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Key inclusion criteria:

1. Documented history of migraine in the 12 months prior to screening

2. 4-14 days per month of migraine symptoms

3. >=80% diary compliance during the Baseline period

Key exclusion criteria:

1. >50 years old at migraine onset

2. Pregnant or nursing

3. History of cluster or hemiplegic headache

4. Evidence of seizure or major psychiatric disorder

5. Score of 19 or higher on the BDI

6. Active chronic pain syndrome

7. Cardiac or hepatic disease

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders

Intervention

Biological:
• Erenumab
70 mg/mL pre-filled syringe administered subcutaneously

Other:
• Placebo
Matching placebo in pre-filled syringe administered subcutaneously

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As
Argentina	Novartis Investigative Site	Cordoba
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Bangalore	Karnataka
India	Novartis Investigative Site	Bangalore	Karnataka
India	Novartis Investigative Site	Belagavi
India	Novartis Investigative Site	Chennai	Tamil Nadu
India	Novartis Investigative Site	DehraDun	Uttarakhand
India	Novartis Investigative Site	Guntur	Andhra Pradesh
India	Novartis Investigative Site	Hyderabad	Telangana
India	Novartis Investigative Site	Kochi	Kerala
India	Novartis Investigative Site	Kochi	Kerala
India	Novartis Investigative Site	Kolkata	West Bengal
India	Novartis Investigative Site	Kolkata	West Bengal
India	Novartis Investigative Site	Kozhikode	Kerala
India	Novartis Investigative Site	Lucknow	Uttar Pradesh
India	Novartis Investigative Site	Ludhiana	Punjab
India	Novartis Investigative Site	Mumbai
India	Novartis Investigative Site	Mumbai	Maharashtra
India	Novartis Investigative Site	Mumbai	Maharashtra
India	Novartis Investigative Site	Mysore	Karnataka
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nashik	Maharashtra
India	Novartis Investigative Site	Nashik	Maharashtra
India	Novartis Investigative Site	New Delhi	Delhi
India	Novartis Investigative Site	New Delhi	Delhi
India	Novartis Investigative Site	New Delhi
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Thiruvananthapuram	Kerala
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Daejeon	Korea
Korea, Republic of	Novartis Investigative Site	Gwangju
Korea, Republic of	Novartis Investigative Site	Gyeonggi do
Korea, Republic of	Novartis Investigative Site	Hwaseong si	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	KOR
Korea, Republic of	Novartis Investigative Site	Seoul	KOR
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	El Chouf	LBN
Malaysia	Novartis Investigative Site	Kuala Lumpur	MYS
Malaysia	Novartis Investigative Site	Kuala Lumpur	Wilayah Persekutuan
Malaysia	Novartis Investigative Site	Kuala Lumpur
Malaysia	Novartis Investigative Site	Seberang Jaya	Pulau Pinang
Malaysia	Novartis Investigative Site	Sungai Buloh	Selangor
Mexico	Novartis Investigative Site	Chihuahua
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Monterrey	Nuevo Leon
Philippines	Novartis Investigative Site	Manila	Metro Manila
Philippines	Novartis Investigative Site	Manila	Metro Manila
Philippines	Novartis Investigative Site	Pasig City
Philippines	Novartis Investigative Site	Quezon City
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Taiwan	Novartis Investigative Site	Chia-Yi
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taichung County
Taiwan	Novartis Investigative Site	Tainan
Taiwan	Novartis Investigative Site	Tainan
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taoyuan
Thailand	Novartis Investigative Site	Bangkok	THA
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chiang Mai
Thailand	Novartis Investigative Site	Khon Kaen	THA
Vietnam	Novartis Investigative Site	Hanoi
Vietnam	Novartis Investigative Site	Ho Chi Minh	VNM

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  India,  Korea, Republic of,  Lebanon,  Malaysia,  Mexico,  Philippines,  Singapore,  Taiwan,  Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP)	A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for = 30 minutes, and meeting at least one of the following criteria: = 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity; = 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia	Baseline up to Month 3
Secondary	Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 3	Achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3. A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for = 30 minutes, and meeting at least one of the following criteria: = 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity; = 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia	Baseline and at Month 3
Secondary	Change From Baseline in Acute Migraine-specific Medication Treatment Days at Month 3	Number of days on which acute migraine-specific medications were used were recorded in eDiary between each monthly IP dose. Migraine-Specific medications include two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. Monthly migraine-specific medication use at baseline is the number of migraine-specific medication treatment days in the baseline period.	Baseline up to Month 3
Secondary	Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at Month 3	The HIT-6 is a short-form self-administered questionnaire based on the internet-HIT question pool. The HIT-6 was developed as a global measure of adverse headache impact to assess headache severity in the previous month and change in a patient's clinical status over a short period of time. Six items assess the frequency of pain severity, headaches limiting daily activity (household, work, school, and social). Each of the 6 questions is responded to using 1 of 5 response categories: "never," "rarely," "sometimes," "very often," or "always." For each HIT-6 item, 6, 8, 10, 11, or 13 points, respectively, are assigned to the response provided. These points were summed to produce a total HIT-6 score that ranges from 36 to 78. Scores were categorized into 4 grades, representing little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78) due to headache. Lower values represent better outcomes, therefore negative change denotes improveme	Baseline up to Month 3

External Links

•   A Plain Language Trial Summary is available on novartisclinicaltrials.com