Episodic Migraine Clinical Trial
— EMPOwEROfficial 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)
Verified date | October 2021 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Argentina, India, Korea, Republic of, Lebanon, Malaysia, Mexico, Philippines, Singapore, Taiwan, Thailand, Vietnam,
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 |
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