Clinical trial NCT03333109: Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Episodic Migraine
Keywords: AMG334
erenumab
episodic migraine
headache
CGRP
Calcitonin Gene-related
migraine
adult
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP)
timeFrame: Baseline up to Month 3
Secondary outcomes:
measure: Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 3
timeFrame: Baseline and at Month 3
measure: Change From Baseline in Acute Migraine-specific Medication Treatment Days at Month 3
timeFrame: Baseline up to Month 3
measure: Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at Month 3
timeFrame: Baseline up to Month 3
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Guntur
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: New Delhi
country: India
facility: Novartis Investigative Site
state: Delhi
city: New Delhi
country: India
facility: Novartis Investigative Site
state: Delhi
city: Ahmedabad
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Mysore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Kochi
country: India
facility: Novartis Investigative Site
state: Kerala
city: Kochi
country: India
facility: Novartis Investigative Site
state: Kerala
city: Kozhikode
country: India
facility: Novartis Investigative Site
state: Kerala
city: Thiruvananthapuram
country: India
facility: Novartis Investigative Site
state: Kerala
city: Mumbai
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Mumbai
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nashik
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nashik
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Ludhiana
country: India
facility: Novartis Investigative Site
state: Punjab
city: Chennai
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Telangana
city: Lucknow
country: India
facility: Novartis Investigative Site
state: Uttar Pradesh
city: DehraDun
country: India
facility: Novartis Investigative Site
state: Uttarakhand
city: Kolkata
country: India
facility: Novartis Investigative Site
state: West Bengal
city: Kolkata
country: India
facility: Novartis Investigative Site
state: West Bengal
city: Belagavi
country: India
facility: Novartis Investigative Site
city: Mumbai
country: India
facility: Novartis Investigative Site
city: New Delhi
country: India
facility: Novartis Investigative Site
city: Hwaseong si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Daejeon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: KOR
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: KOR
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Gwangju
country: Korea, Republic of
facility: Novartis Investigative Site
city: Gyeonggi do
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: El Chouf
country: Lebanon
facility: Novartis Investigative Site
state: LBN
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
state: MYS
city: Seberang Jaya
country: Malaysia
facility: Novartis Investigative Site
state: Pulau Pinang
city: Sungai Buloh
country: Malaysia
facility: Novartis Investigative Site
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
state: Nuevo Leon
city: Chihuahua
country: Mexico
facility: Novartis Investigative Site
city: Manila
country: Philippines
facility: Novartis Investigative Site
state: Metro Manila
city: Manila
country: Philippines
facility: Novartis Investigative Site
state: Metro Manila
city: Pasig City
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Chia-Yi
country: Taiwan
facility: Novartis Investigative Site
city: Taichung County
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taoyuan
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
state: THA
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
state: THA
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Ho Chi Minh
country: Vietnam
facility: Novartis Investigative Site
state: VNM
city: Hanoi
country: Vietnam
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.
citation: Wang SJ, Roxas AA Jr, Saravia B, Kim BK, Chowdhury D, Riachi N, Tai MS, Tanprawate S, Ngoc TT, Zhao YJ, Mikol DD, Pandhi S, Wen S, Mondal S, Tenenbaum N, Hours-Zesiger P. Randomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: The EMPOwER study. Cephalalgia. 2021 Nov;41(13):1285-1297. doi: 10.1177/03331024211024160. Epub 2021 Jun 25.