Clinical Trials List
2019-08-19 - 2024-04-30
Phase III
Recruiting2
Terminated7
A 12-week phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once monthly subcutaneous erenumab 70 mg in adult chronic migraine patients
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 陳世彬 未分科
- 陳世彬 無
- Jong-Ling Fuh 無
- 賴冠霖 無
- YEN-FENG WANG 無
- 陳韋達 無
- Hung-Yu Liu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Chon-Haw Tsai 未分科
The Actual Total Number of Participants Enrolled
14 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
compared to placebo by measuring the change in monthly migraine days (MMD)
from baseline to the last 4 weeks of the 12-week treatment period.
Secondary Objectives:
Objective 1: To evaluate the effect of erenumab compared to placebo on change
in migraine-related disability and productivity as measured by the modified
Migraine Disability Assessment (mMIDAS) from baseline to the last 4 weeks of
the 12-week treatment period
Objective 2: To evaluate the effect of erenumab compared to placebo on the
proportion of subjects with at least 50% reduction in monthly migraine days from
baseline to the last 4 weeks of the 12-week treatment period
Objective 3: To evaluate the effect of erenumab compared to placebo on the
change in monthly acute headache medication days from baseline to the last 4
weeks of the 12-week treatment period
Objective 4: To evaluate the safety and tolerability of erenumab, including
adverse events (AEs), clinical laboratory values, vital signs, and anti-AMG 334
antibodies
Inclution Criteria
History of at least 5 attacks of migraine (with or without aura) based on
medical records and/or patient self-report
History of ≥ 15 headache days per month of which ≥ 8 headache days were
assessed by the subject as migraine days per month in each of the 3 months
prior to screening
≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine
days during the baseline period based on the electronic Diary (eDiary)
calculation (Refer to Section 8.3.1 for definition of migraine day)
Demonstrated at least 80% compliance with the eDiary during the baseline
period based on the eDiary calculation
Exclusion Criteria
Taken an opioid and/or opioid-containing analgesic for any indication on
greater than 4 days within one month prior to the start of the baseline period
or during the baseline period
Taken a butalbital-containing analgesic for any indication on greater than 2
days within one month prior to the start of the baseline period or during the
baseline period
More than 3 prior migraine prophylaxis treatments failure out of the following
categories:
Category 1: Divalproex sodium, sodium valproate
Category 2: Topiramate
Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol,
nadolol, nebivolol, pindolol, propranolol, timolol)
Category 4: Tricyclic antidepressants (for example: amitriptyline,
nortriptyline, protriptyline)
Category 5: Flunarizine, verapamil, cinnarizine
Category 6: Serotonin-norepinephrine reuptake inhibitors (for example:
venlafaxine, desvenlafaxine, duloxetine, milnacipran)
Category 7: Botulinum toxin
Category 8: lisinopril, candesartan
Category 9: Pregabalin, gabapentin, zonisamide, memantine, pizotifen
Use of a prohibited medication for migraine prophylaxis within 5 half-lives, or
a device or procedure for migraine prophylaxis within one month prior to the
start of the baseline period or throughout the study (Refer to Section 6.2.2
for the list of these excluded therapies)
Prior Botulinum toxin A treatment in the head/neck region within 4 months
prior to the start of the baseline period or during the baseline period
The Estimated Number of Participants
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Taiwan
145 participants
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Global
557 participants
