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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03333109
Other study ID # CAMG334A2302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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