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

Phase 3

Completed

• Conditions: Episodic Migraine
• Interventions: Biological: Erenumab; Other: Placebo

• Registration Number: NCT03333109
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-06
• Study Start: 2018-02-08
• Primary Completion: 2020-01-13
• Study Completion: 2020-01-13
• Results First Submitted: 2021-01-11
• Results First Submitted QC: 2021-03-06
• Results First Posted: 2021-03-09
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG334 140 mg	Erenumab	AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
Placebo	Placebo	Two pre-filled syringes containing placebo identical in appearance to erenumab
AMG334 70 mg	Erenumab	AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP)	Baseline up to 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: 1. ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity; 2. ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Acute Migraine-specific Medication Treatment Days at Month 3	Baseline up to 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.
Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at Month 3	Baseline up to 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
Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 3	Baseline and 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: 1. ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity; 2. ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia

Trial Locations

Locations (1)

Novartis Investigative Site; 🇻🇳 Hanoi, Vietnam